| ▶ 계측기기 |
| EN 61010-1:2010 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
[Exception]
6.7.1.3 CREEPAGE DISTANCES -The test for tracking index
9.3.2 Constructional requirements - Flammability tests
10.5.3 Insulating materials 2) The Vicat softening test of ISO 306, method A120
11.6 Specially protected equipment (IPX1 ~ IPX6)
11.7 Fluid pressure & leakage
12.2.1 Ionizing radiation
12.3 Ultraviolet (UV) radiation
12.4 Microwave Radiation
12.5.2 Ultrasonic pressure
12.6 Laser sources
13.2.3 Implosion of cathode ray tubes
14.7 Printed wiring boards - Flammability tests
14.8 Circuits or components used as TRANSIENT OVERVOLTAGE limiting devices
Annex H Qualification of conformal coatings for protection against pollution |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 61010-2-201:2013 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-201: Particular requirements for control equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-101:2022+A11:2022 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 61010-2-101:2017 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-051:2021+A11:2021 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-051: Particular requirements for laboratory equipment for mixing and stirring |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-091:2021+A11:2021 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 61010-2-051:2015 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-051: Particular requirements for laboratory equipment for mixing and stirring |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-040:2021 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
[Exception]
13.1 Poisonous and injurious gases and substances
13.101 Other HAZARDS arising from the use of toxic sterilants |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 61010-2-040:2015 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
[Exception]
13.1 Poisonous and injurious gases and substances
13.101 Other HAZARDS arising from the use of toxic sterilants |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 61010-2-020:2017 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
[Exception]
7.3 Moving parts
7.7 Expelled parts
Annex AA Dynamic microbiological test method for BIOSEALS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-012:2022+A11:2022 |
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-012: Particular requirements for climatic and environmental testing and other temperature conditioning equipment
[Exception]
11.4.101 Salt mist, thawing, condensate and spray
11.7.2.102.2 Pressure test
11.7.101.4 Scratch test for protected refrigerating systems
11.7.101.5 Unprotected refrigerating systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-011:2021+A11:2021 |
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-011: Particular requirements for REFRIGERATING EQUIPMENT
[Exception]
10.101 Protection against cold surfaces
11.7.102.2 Pressure test
11.7.104.4 Scratch test
11.7.104.5 Unprotected refrigerating systems
11.7.104.8 Transport temperature test |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-010:2020 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
[Exception]
5.4.4.101 Cleaning and decontamination
8.2.101 Dynamic test of horizontal heating surfaces of glass or ceramic material |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 61010-1:2010+A1:2019 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
[Exception]
6.7.1.3 CREEPAGE DISTANCES -The test for tracking index
9.3.2 Constructional requirements - Flammability tests
10.5.3 Insulating materials 2) The Vicat softening test of ISO 306, method A120
11.6 Specially protected equipment (IPX1 ~ IPX6)
11.7 Fluid pressure & leakage
12.2.1 Ionizing radiation
12.3 Ultraviolet (UV) radiation
12.4 Microwave Radiation
12.5.2 Ultrasonic pressure
12.6 Laser sources
13.2.3 Implosion of cathode ray tubes
14.7 Printed wiring boards - Flammability tests
14.8 Circuits or components used as TRANSIENT OVERVOLTAGE limiting devices
Annex H Qualification of conformal coatings for protection against pollution |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 61010-2-201:2018 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-201: Particular requirements for control equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-1:2010 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
[Exception]
6.7.1.3 CREEPAGE DISTANCES -The test for tracking index
9.3.2 Constructional requirements - Flammability tests
10.5.3 Insulating materials 2) The Vicat softening test of ISO 306, method A120
11.6 Specially protected equipment (IPX1 ~ IPX6)
11.7 Fluid pressure & leakage
12.2.1 Ionizing radiation
12.3 Ultraviolet (UV) radiation
12.4 Microwave Radiation
12.5.2 Ultrasonic pressure
12.6 Laser sources
13.2.3 Implosion of cathode ray tubes
14.7 Printed wiring boards - Flammability tests
14.8 Circuits or components used as TRANSIENT OVERVOLTAGE limiting devices
Annex H Qualification of conformal coatings for protection against pollution |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-1:2010+A1:2016 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
[Exception]
6.7.1.3 CREEPAGE DISTANCES -The test for tracking index
9.3.2 Constructional requirements - Flammability tests
10.5.3 Insulating materials 2) The Vicat softening test of ISO 306, method A120
11.6 Specially protected equipment (IPX1 ~ IPX6)
11.7 Fluid pressure & leakage
12.2.1 Ionizing radiation
12.3 Ultraviolet (UV) radiation
12.4 Microwave Radiation
12.5.2 Ultrasonic pressure
12.6 Laser sources
13.2.3 Implosion of cathode ray tubes
14.7 Printed wiring boards - Flammability tests
14.8 Circuits or components used as TRANSIENT OVERVOLTAGE limiting devices
Annex H Qualification of conformal coatings for protection against pollution |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-201:2017 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-201: Particular requirements for control equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-201:2013 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-201: Particular requirements for control equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-101:2018 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-101:2015 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-091:2019 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-091: Particular requirements for cabinet X-ray systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 61010-2-051:2018 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-051: Particular requirements for laboratory equipment for mixing and stirring |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-051:2015 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-051: Particular requirements for laboratory equipment for mixing and stirring |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-040:2020 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
[Exception]
13.1 Poisonous and injurious gases and substances
13.101 Other HAZARDS arising from the use of toxic sterilants |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-040:2015 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
[Exception]
13.1 Poisonous and injurious gases and substances
13.101 Other HAZARDS arising from the use of toxic sterilants |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-020:2016 |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
[Exception]
7.3 Moving parts
7.7 Expelled parts
Annex AA Dynamic microbiological test method for BIOSEALS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-012:2019 |
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-012: Particular requirements for climatic and environmental testing and other temperature conditioning equipment
[Exception]
11.4.101 Salt mist, thawing, condensate and spray
11.7.2.102.2 Pressure test
11.7.101.4 Scratch test for protected refrigerating systems
11.7.101.5 Unprotected refrigerating systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-011:2019 |
Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-011: Particular requirements for REFRIGERATING EQUIPMENT
[Exception]
10.101 Protection against cold surfaces
11.7.102.2 Pressure test
11.7.104.4 Scratch test
11.7.104.5 Unprotected refrigerating systems
11.7.104.8 Transport temperature test |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 61010-2-010:2019 |
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
[Exception]
5.4.4.101 Cleaning and decontamination
8.2.101 Dynamic test of horizontal heating surfaces of glass or ceramic material |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ▶ 가정용 전기기기 |
| EN IEC 62368-1:2020+A11:2020 |
Audio/video, information and communication technology equipment - Part 1: Safety requirements
[Exception]
4.7 Equipment for direct insertion into mains socket-outlets
5.4.1.10 Thermoplastic parts on which conductive metallic parts are directly mounted
5.4.2, 5.4.3, 5.4.4, Annex X Clearances, creepage distance, solid insulation - Test equipment for tracking index per IEC 60112, Mandrel (figure 25 to 28)
5.4.12 Insulating liquid
5.6.4.1 Requirements (Annex R)
6.3.1 Requirements - Test equipment for glow-wire flammability test per IEC 60695-2-11
6.4.8 Fire enclosures and fire barriers - Test equipment for needle flame burner per IEC 60695-11-5
8.5.5.2. Test method - High pressure lamps
9.6.3 Test method and compliance criteria - Wireless power transmitters
10 Radiation
Annex B.3.2 Covering of ventilation openings
Annex C UV radiation
Annex E Test conditions for equipment containing audio amplifiers
Annex G.5.3.4 Transformers using fully insulated winding wire (FIW)
Annex G.7 Mains supply cords
Annex G.10 Test for resistor serving as safeguard Test sequence
Annex G.13.6.2 Test method and compliance criteria
Annex G.15 Pressurized liquid filled components
Annex J Insulated winding wires for use without interleaved insulation
Annex M.7 Risk of explosion from lead acid and NiCd batteries
Annex M.8 Protection against internal ignition from external spark sources of batteries with aqueous electrolyte
Annex P.2 Safeguards against entry or consequences of entry of a foreign object
Annex S Tests for resistance to heat and fire
Annex T 10 Fragmentation test
Annex U Mechanical strength of CRTs and protection against the effects of implosion
Annex V.1.6 Test method 5 - Terminals intended to be used by an ordinary person
Annex Y.2 Resistance to UV radiation
Annex Y.3 Resistance to corrosion
Annex Y.3.3 Water – saturated sulphur dioxide atmosphere
Annex Y.4.3 Tensile strength and elongation tests
Annex Y.4.4 Compression test
Annex Y.4.5 Oil resistance
Annex Y.5 Protection of equipment within an outdoor enclosure
Annex Y.5.3 Water spray test
Annex Y.5.5 Protection from excessive dust |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 62368-1:2024+A11:2024 |
Audio/video, information and communication technology equipment - Part 1: Safety requirements
[Exception]
4.7 Equipment for direct insertion into mains socket-outlets
5.4.1.10 Thermoplastic parts on which conductive metallic parts are directly mounted
5.4.2, 5.4.3, 5.4.4, Annex X Clearances, creepage distance, solid insulation - Test equipment for tracking index per IEC 60112, Mandrel (figure 25 to 28)
5.4.12 Insulating liquid
5.6.4.1 Requirements (Annex R)
6.3.1 Requirements - Test equipment for glow-wire flammability test per IEC 60695-2-11
6.4.8 Fire enclosures and fire barriers - Test equipment for needle flame burner per IEC 60695-11-5
8.5.5.2. Test method - High pressure lamps
9.6.3 Test method and compliance criteria - Wireless power transmitters
10 Radiation
Annex B.3.2 Covering of ventilation openings
Annex C UV radiation
Annex E Test conditions for equipment intended to amplify audio signals
Annex G.5.3.4 Transformers using fully insulated winding wire (FIW)
Annex G.7 Mains supply cords
Annex G.10 Test for resistor serving as safeguard Test sequence
Annex G.13.6.2 Test method and compliance criteria
Annex G.15 Pressurized liquid filled components
Annex J Insulated winding wires for use without interleaved insulation
Annex M.7 Risk of explosion from lead acid and NiCd batteries
Annex M.8 Protection against internal ignition from external spark sources of batteries with aqueous electrolyte
Annex P.2 Safeguards against entry or consequences of entry of a foreign object
Annex S Tests for resistance to heat and fire
Annex T 10 Fragmentation test
Annex U Mechanical strength of CRTs and protection against the effects of implosion
Annex V.1.6 Test method 5 - Terminals intended to be used by an ordinary person
Annex Y.2 Resistance to UV radiation
Annex Y.3 Resistance to corrosion
Annex Y.3.3 Water – saturated sulphur dioxide atmosphere
Annex Y.4.3 Tensile strength and elongation tests
Annex Y.4.4 Compression test
Annex Y.4.5 Oil resistance
Annex Y.5 Protection of equipment within an outdoor enclosure
Annex Y.5.3 Water spray test
Annex Y.5.5 Protection from excessive dust |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 62368-3:2020 |
Audio/video, information and communication technology equipment – Part 3: Safety aspects for DC power transfer through communication cables and ports |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60950-1:2005+A1:2009+A2:2013 |
Information technology equipment - Safety - Part 1: General requirements
[Exception]
2.1.1.9 Audio amplifiers in information technology equipment
2.3.1 Limits - TNV circuits
2.3.4 Connection of TNV circuits to other circuits
2.3.5 Test for operating voltages generated externally
2.10.3.9 Measurement of transient voltages
2.10.4 Creepage distances - The test for tracking index
2.10.5.4 Semiconductor devices
2.10.7 Component external terminations
2.10.8.4 Abrasion resistance test
3.2.5.1 AC Power supply cords
4.2.8 Cathode ray tubes
4.3.6 Direct plug-in equipment
4.3.12 Flammable liquids
4.3.13 Radiation (Ionizing, UV and laser radiation)
4.6.2 Bottom of fire enclosures
4.6.4.2 Evaluation measures for larger openings
4.7.3 Materials - Annex A
4.7.3.6 Materials used in high-voltage components
6.2.2.3 Compliance criteria
7.4.2 Voltage surge test
Annex U Insulated winding wires for use without interleaved insulation
7.4.3 Impulse test
Annex Q Voltage dependent resistors (VDRs)
Annex AA Mandrel test
Annex B.4 Running overload test
Annex B.6 Running overload test for d.c. motors in secondary circuits
Annex B.9 Test for three-phase motors
Annex CC Evaluation of integrated circuit (IC) current limiters
Annex EE Household and home/office document/media shredders |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 62368-1:2018 |
Audio/video, information and communication technology equipment - Part 1: Safety requirements
[Exception]
4.7 Equipment for direct insertion into mains socket-outlets
5.4.1.10 Thermoplastic parts on which conductive metallic parts are directly mounted
5.4.2, 5.4.3, 5.4.4, Annex X Clearances, creepage distance, solid insulation - Test equipment for tracking index per IEC 60112, Mandrel (figure 25 to 28)
5.4.12 Insulating liquid
5.6.4.1 Requirements (Annex R)
6.3.1 Requirements - Test equipment for glow-wire flammability test per IEC 60695-2-11
6.4.8 Fire enclosures and fire barriers - Test equipment for needle flame burner per IEC 60695-11-5
8.5.5.2. Test method - High pressure lamps
9.6.3 Test method and compliance criteria - Wireless power transmitters
10 Radiation
Annex B.3.2 Covering of ventilation openings
Annex C UV radiation
Annex E Test conditions for equipment containing audio amplifiers
Annex G.5.3.4 Transformers using fully insulated winding wire (FIW)
Annex G.7 Mains supply cords
Annex G.10 Test for resistor serving as safeguard Test sequence
Annex G.13.6.2 Test method and compliance criteria
Annex G.15 Pressurized liquid filled components
Annex J Insulated winding wires for use without interleaved insulation
Annex M.7 Risk of explosion from lead acid and NiCd batteries
Annex M.8 Protection against internal ignition from external spark sources of batteries with aqueous electrolyte
Annex P.2 Safeguards against entry or consequences of entry of a foreign object
Annex S Tests for resistance to heat and fire
Annex T 10 Fragmentation test
Annex U Mechanical strength of CRTs and protection against the effects of implosion
Annex V.1.6 Test method 5 - Terminals intended to be used by an ordinary person
Annex Y.2 Resistance to UV radiation
Annex Y.3 Resistance to corrosion
Annex Y.3.3 Water – saturated sulphur dioxide atmosphere
Annex Y.4.3 Tensile strength and elongation tests
Annex Y.4.4 Compression test
Annex Y.4.5 Oil resistance
Annex Y.5 Protection of equipment within an outdoor enclosure
Annex Y.5.3 Water spray test
Annex Y.5.5 Protection from excessive dust |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 62368-1:2023 |
Audio/video, information and communication technology equipment - Part 1: Safety requirements
[Exception]
4.7 Equipment for direct insertion into mains socket-outlets
5.4.1.10 Thermoplastic parts on which conductive metallic parts are directly mounted
5.4.2, 5.4.3, 5.4.4, Annex X Clearances, creepage distance, solid insulation - Test equipment for tracking index per IEC 60112, Mandrel (figure 25 to 28)
5.4.12 Insulating liquid
5.6.4.1 Requirements (Annex R)
6.3.1 Requirements - Test equipment for glow-wire flammability test per IEC 60695-2-11
6.4.8 Fire enclosures and fire barriers - Test equipment for needle flame burner per IEC 60695-11-5
8.5.5.2. Test method - High pressure lamps
9.6.3 Test method and compliance criteria - Wireless power transmitters
10 Radiation
Annex B.3.2 Covering of ventilation openings
Annex C UV radiation
Annex E Test conditions for equipment intended to amplify audio signals
Annex G.5.3.4 Transformers using fully insulated winding wire (FIW)
Annex G.7 Mains supply cords
Annex G.10 Test for resistor serving as safeguard Test sequence
Annex G.13.6.2 Test method and compliance criteria
Annex G.15 Pressurized liquid filled components
Annex J Insulated winding wires for use without interleaved insulation
Annex M.7 Risk of explosion from lead acid and NiCd batteries
Annex M.8 Protection against internal ignition from external spark sources of batteries with aqueous electrolyte
Annex P.2 Safeguards against entry or consequences of entry of a foreign object
Annex S Tests for resistance to heat and fire
Annex T 10 Fragmentation test
Annex U Mechanical strength of CRTs and protection against the effects of implosion
Annex V.1.6 Test method 5 - Terminals intended to be used by an ordinary person
Annex Y.2 Resistance to UV radiation
Annex Y.3 Resistance to corrosion
Annex Y.3.3 Water – saturated sulphur dioxide atmosphere
Annex Y.4.3 Tensile strength and elongation tests
Annex Y.4.4 Compression test
Annex Y.4.5 Oil resistance
Annex Y.5 Protection of equipment within an outdoor enclosure
Annex Y.5.3 Water spray test
Annex Y.5.5 Protection from excessive dust |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 62368-3:2017 |
Audio/video, information and communication technology equipment – Part 3: Safety aspects for DC power transfer through communication cables and ports |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ▶ 의료기기 |
| EN 60601-1:2006+A1:2013+A12:2014 |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
[Exception]
8.8.4.2 Resistance to environmental stress - Requirements of insulating material for rubber
8.9.1.7 Material groups classification
9.5.2 Cathode ray tubes
10.3 Microwave radiation
10.4 Lasers
11.2 Fire prevention
11.3 Constructional requirements for fire enclosures of ME EQUIPMENT
11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics
11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS - from IPX1 to IPX 6
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
15.4.2 Temperature and overload control devices
15.4.3.4 Lithium batteries
15.4.7.3 Entry of liquids
Annex A 10.4 Laser
Annex G(normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures
Annex G.4.3 Prevention of electrostatic charges
Annex L(normative) Insulated winding wires for use without interleaved insulation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-1:2006+A1:2013+A12:2014+A2:2021 |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
[Exception]
8.8.4.2 Resistance to environmental stress - Requirements of insulating material for rubber
8.9.1.7 Material groups classification
9.5.2 Cathode ray tubes
10.3 Microwave radiation
10.4 Lasers
11.2 Fire prevention
11.3 Constructional requirements for fire enclosures of ME EQUIPMENT
11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics
11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS - from IPX1 to IPX 6
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
15.4.2 Temperature and overload control devices
15.4.3.4 Lithium batteries
15.4.7.3 Entry of liquids
Annex A 10.4 Laser
Annex G(normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures
Annex G.4.3 Prevention of electrostatic charges
Annex L(normative) Insulated winding wires for use without interleaved insulation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-1-3:2008+A1:2013 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-1-3:2008+A1:2013+A11:2016 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-1-3:2008+A1:2013+A11:2016+A2:2021 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-1-6:2010+A1:2015 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard : Usability |
— |
소재지 |
| ISO 80601-2-56:2017 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-90:2021 |
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-87:2021 |
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.6.2.1.101 Additional requirements for audible acoustic energy
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME equipment or ME system
201.15.3.5.101 Additional requirements for rough handling |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-2:2017+A1:2023 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
[Exception]
201.15.101.5 NE thermal performance |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-55:2018+A1:2023 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratorygasmonitors
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS (from IPX1 to IPX6)
201.15.3.5.101.2 Shock and vibration for stand-alone RGM (robustness) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-22:2007+A1:2012 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
[Exception]
201.10.4 Lasers and light emitting diodes(LEDs) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-22:2007 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
[Exception]
201.10.4 Lasers and light emitting diodes(LEDs) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-18:2009 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-12:2023 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators
[Exception]
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEM - from IPX1 to IPX 6 |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-12:2020 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators
[Exception]
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEM - from IPX1 to IPX 6 |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-12:2011 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators
[Exception]
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEM - from IPX1 to IPX 6 |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-10:2012+A1:2016+A2:2023 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-10:2012+A1:2016 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-5:2009 |
Medical electrical equipment - Part 2-5: particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
[Exception]
201.10.102 Unwanted ultrasound radiation
201.12 Accuracy of controls and instruments and protection against hazardous outputs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-4:2010+A1:2018 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-4:2010 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-80:2018 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-79:2019 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-78:2020 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-77:2021+A1:2023 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-77:2021 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-74:2021 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy
201.9.6.2.1.102 Additional requirements for audible acoustic energy for use with an incubator |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-72:2023 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-71:2018 |
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-65:2013+A1:2020+A2:2021 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-65:2013+A1:2020 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-63:2015+A1:2019+A2:2021 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-63:2015+A1:2019 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-63:2015 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-62:2015 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-61:2019 |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
[Exception]
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEM(from IPX1 to IPX6) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-60:2020 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
[Exception]
201.10.4 Lasers and light-emitting diodes (LED) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-80:2019 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-87:2021 |
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.6.2.1.101 Additional requirements for audible acoustic energy
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME equipment or ME system
201.15.3.5.101 Additional requirements for rough handling |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-4:2011 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 60601-2-2:2018 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
[Exception]
201.15.101.5 NE thermal performance |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-1-12:2015+A1:2020 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
[Exception]
7 Protection against electrical HAZARDS from ME EQUIPMENT - IP54
8.1 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
10.1.2 Requirements for mechanical strength for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT intended for use in a road ambulance
10.1.3 Requirements for mechanical strength for TRANSPORTABLE ME EQUIPMENT
10.1.4 Requirements for mechanical strength for ME EQUIPMENT intended for airborne use
11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-1-12:2015 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
[Exception]
7 Protection against electrical HAZARDS from ME EQUIPMENT - IP54
8.1 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
10.1.2 Requirements for mechanical strength for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT intended for use in a road ambulance
10.1.3 Requirements for mechanical strength for TRANSPORTABLE ME EQUIPMENT
10.1.4 Requirements for mechanical strength for ME EQUIPMENT intended for airborne use
11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-1-11:2015+A1:2021 |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
[Exception]
8.3.1 Ingress of water or particulate matter into ME EQUIPMENT / IP testing
8.3.2 Ingress of water or particulate matter into ME SYSTEMS / IP Testing
10.1.2 Requirements for Mechanical strength for NON-TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
10.1.3 Requirements for Mechanical strength for TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
12 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS / Emissions classification |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-1-11:2015 |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
[Exception]
8.3.1 Ingress of water or particulate matter into ME EQUIPMENT / IP testing
8.3.2 Ingress of water or particulate matter into ME SYSTEMS / IP Testing
10.1.2 Requirements for Mechanical strength for NON-TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
10.1.3 Requirements for Mechanical strength for TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
12 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS / Emissions classification |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-1-10:2008+A1:2015+A2:2021 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
— |
소재지 |
| EN 60601-1-10:2008+A1:2015 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
— |
소재지 |
| EN 60601-1-9:2008+A1:2013+A2:2020 |
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
— |
소재지 |
| EN 60601-1-9:2008+A1:2013 |
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
— |
소재지 |
| EN 60601-1-8:2007+A1:2013+A11:2017+A2:2021 |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
(70~130) dB |
소재지 |
| EN 60601-1-8:2007+A1:2013+A11:2017 |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
(70~130) dB |
소재지 |
| EN 60601-1-8:2007+A1:2013 |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
(70~130) dB |
소재지 |
| EN 60601-2-43:2010+A1:2018 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
[Exception]
201.11.6.5.103 ENCLOSURES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-43:2010+A1:2018+A2:2020 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
[Exception]
201.11.6.5.103 ENCLOSURES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-57:2011 |
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-56:2017+A1:2020 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-55:2018+A1:2023 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratorygasmonitors
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS (from IPX1 to IPX6)
201.15.3.5.101.2 Shock and vibration for stand-alone RGM (robustness) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-60:2019 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
[Exception]
201.10.4 Lasers and light-emitting diodes (LED) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-60:2012 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
[Exception]
201.10.4 Lasers and light-emitting diodes (LED) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-57:2023 |
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-57:2011 |
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-56:2017+A1:2018 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-65:2012+A1:2017+A2:2021 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 80601-2-71:2015 |
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-72:2015 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-72:2023 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-74:2021 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy
201.9.6.2.1.102 Additional requirements for audible acoustic energy for use with an incubator |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-77:2019 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-77:2019+A1:2023 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-78:2019 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-78:2019+A1:2024 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-79:2018 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-61:2017 |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
[Exception]
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEM(from IPX1 to IPX6) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-62:2013 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-55:2018 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratorygasmonitors
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS (from IPX1 to IPX6)
201.15.3.5.101.2 Shock and vibration for stand-alone RGM (robustness) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-54:2009+A1:2015+A2:2019 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-54:2009+A1:2015 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-52:2010+A1:2015 |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS - from IPX4 to IPX 6 |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-49:2019 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS (from IPX1 to IPX6) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-47:2015 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 60601-2-46:2019 |
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME equipment and ME systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c. |
소재지 |
| EN 60601-2-45:2011+A1:2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
[Exception]
201.9.2.101.3 Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-44:2009+A11:2011+A1:2012+A2:2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN IEC 60601-2-43:2023 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
[Exception]
201.11.6.5.103 ENCLOSURES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-1-6:2010+A1:2015+A2:2021 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard : Usability |
— |
소재지 |
| IEC 60601-2-65:2012+A1:2017 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-63:2012+A1:2017+A2:2021 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-63:2012+A1:2017 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-63:2012 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-4:2011+A1:2019 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-5:2015 |
Medical electrical equipment - Part 2-5: particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
[Exception]
201.10.102 Unwanted ultrasound radiation
201.12 Accuracy of controls and instruments and protection against hazardous outputs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-44:2009+A1:2012+A2:2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-45:2011+A1:2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
[Exception]
201.9.2.101.3 Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-45:2011+A1:2015+A2:2022 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
[Exception]
201.9.2.101.3 Biopsy needle positioning accuracy of MAMMOGRAPHIC STEREOTACTIC DEVICES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-46:2023 |
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME equipment and ME systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c. |
소재지 |
| IEC 60601-2-47:2012 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-49:2011 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS (from IPX1 to IPX6) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-49:2018 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS (from IPX1 to IPX6) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-52:2009+A1:2015 |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS - from IPX4 to IPX 6 |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-54:2009+A1:2015 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-54:2009+A1:2015+A2:2018 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-54:2022 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| ISO 80601-2-55:2011 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratory gas monitors
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS (from IPX1 to IPX6)
201.15.3.5.101.1 Shock and vibration
201.15.3.5.101.2 Shock and vibration for professional transportation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ISO 80601-2-55:2018 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratorygasmonitors
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS (from IPX1 to IPX6)
201.15.3.5.101.2 Shock and vibration for stand-alone RGM (robustness) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-24:2012 |
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
[Exception]
201.11.6.3 Spiliage on ME Equipment and ME Systems
201.11.6.5 Ingress of water or particulate matter into ME Equipment and ME Systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-22:2019 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
[Exception]
201.10.4 Lasers and light emitting diodes(LEDs) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-1:2005+A1:2012+A2:2020 |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
[Exception]
8.8.4.2 Resistance to environmental stress - Requirements of insulating material for rubber
8.9.1.7 Material groups classification
9.5.2 Cathode ray tubes
10.3 Microwave radiation
10.4 Lasers
11.2 Fire prevention
11.3 Constructional requirements for fire enclosures of ME EQUIPMENT
11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics
11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS - from IPX1 to IPX 6
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
15.4.2 Temperature and overload control devices
15.4.3.4 Lithium batteries
15.4.7.3 Entry of liquids
Annex A 10.4 Laser
Annex G(normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures
Annex G.4.3 Prevention of electrostatic charges
Annex L(normative) Insulated winding wires for use without interleaved insulation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-1-3:2008+A1:2013 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-1-3:2008+A1:2013+A2:2021 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-1-6:2010+A1:2013 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard : Usability |
— |
소재지 |
| IEC 60601-1-6:2010+A1:2013+A2:2020 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard : Usability |
— |
소재지 |
| IEC 60601-1-8:2006+A1:2012 |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
(70~130) dB |
소재지 |
| IEC 60601-1-8:2006+A1:2012+A2:2020 |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
(70~130) dB |
소재지 |
| IEC 60601-1-9:2007+A1:2013 |
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
— |
소재지 |
| IEC 60601-1-9:2007+A1:2013+A2:2020 |
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
— |
소재지 |
| IEC 60601-1-10:2007+A1:2013 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
— |
소재지 |
| IEC 60601-1-10:2007+A1:2013+A2:2020 |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
— |
소재지 |
| IEC 60601-1-11:2015 |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
[Exception]
8.3.1 Ingress of water or particulate matter into ME EQUIPMENT / IP testing
8.3.2 Ingress of water or particulate matter into ME SYSTEMS / IP Testing
10.1.2 Requirements for Mechanical strength for NON-TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
10.1.3 Requirements for Mechanical strength for TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
12 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS / Emissions classification |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-1-11:2015+A1:2020 |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
[Exception]
8.3.1 Ingress of water or particulate matter into ME EQUIPMENT / IP testing
8.3.2 Ingress of water or particulate matter into ME SYSTEMS / IP Testing
10.1.2 Requirements for Mechanical strength for NON-TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
10.1.3 Requirements for Mechanical strength for TRANSIT-OPERABLE ME EQUIPMENT / Shock and Vibration
12 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS / Emissions classification |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-1-12:2014 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
[Exception]
7 Protection against electrical HAZARDS from ME EQUIPMENT - IP54
8.1 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
10.1.2 Requirements for mechanical strength for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT intended for use in a road ambulance
10.1.3 Requirements for mechanical strength for TRANSPORTABLE ME EQUIPMENT
10.1.4 Requirements for mechanical strength for ME EQUIPMENT intended for airborne use
11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-1-12:2014+A1:2020 |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
[Exception]
7 Protection against electrical HAZARDS from ME EQUIPMENT - IP54
8.1 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
10.1.2 Requirements for mechanical strength for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT intended for use in a road ambulance
10.1.3 Requirements for mechanical strength for TRANSPORTABLE ME EQUIPMENT
10.1.4 Requirements for mechanical strength for ME EQUIPMENT intended for airborne use
11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-2:2009+CORR.1:2014 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
[Exception]
201.15.101.5 NE thermal performance |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-43:2022 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
[Exception]
201.11.6.5.103 ENCLOSURES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-43:2010+A1:2017+A2:2019 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
[Exception]
201.11.6.5.103 ENCLOSURES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN 60601-2-10:2015+A1:2016 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN ISO 80601-2-12:2023 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators
[Exception]
201.11.6.5.101 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEM - from IPX1 to IPX 6 |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-18:2015 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 60601-2-22:2020 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
[Exception]
201.10.4 Lasers and light emitting diodes(LEDs) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-24:2015 |
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
[Exception]
201.11.6.3 Spiliage on ME Equipment and ME Systems
201.11.6.5 Ingress of water or particulate matter into ME Equipment and ME Systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-25:2015 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-26:2020 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 80601-2-26:2020+A1:2024 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-27:2014 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 60601-2-28:2019 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| EN IEC 80601-2-30:2019 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
[Exception]
201.15.3.5.101 Shock and vibration (robustness)
202 Electromagnetic disturbances – Requirements and tests |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-34:2014 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
[Exception]
201.12.1.101.2 Accuracy of systolic and diastolic pressure
201.12.1.101.3 Frequency response |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-36:2015 |
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN 60601-2-37:2008+A11:2011+A1:2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
[Exception]
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS (IPX1) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| EN IEC 60601-2-41:2021 |
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
[Exception]
201.10.5.103.3 Chromaticity
201.10.5.103.4 Colour rendering
201.10.6 Infrared radiation
201.10.7 Ultraviolet radiation
201.10.101 Broadband radiation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Illuminance: Up to 180 000 lx
Distance: 5.5 m |
소재지 |
| EN ISO 80601-2-90:2021 |
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
[Exception]
201.4.11.101 Additional requirements for pressurized gas input
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
201.9.6.2.1.101 Additional requirements for audible acoustic energy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-1:2005+A1:2012 |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
[Exception]
8.8.4.2 Resistance to environmental stress - Requirements of insulating material for rubber
8.9.1.7 Material groups classification
9.5.2 Cathode ray tubes
10.3 Microwave radiation
10.4 Lasers
11.2 Fire prevention
11.3 Constructional requirements for fire enclosures of ME EQUIPMENT
11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics
11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS - from IPX1 to IPX 6
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
15.4.2 Temperature and overload control devices
15.4.3.4 Lithium batteries
15.4.7.3 Entry of liquids
Annex A 10.4 Laser
Annex G(normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures
Annex G.4.3 Prevention of electrostatic charges
Annex L(normative) Insulated winding wires for use without interleaved insulation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-25:2011 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-26:2012 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
[Exception]
201.11.6.3 Spillage on ME Equipment and ME Systems |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-26:2019 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-26:2019+A1:2024 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-27:2011+CORR.1:2012 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
[Exception]
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-28:2010 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-28:2017 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 80601-2-30:2009+A1:2013 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
[Exception]
201.15.3.5.101 Shock and vibration for other than transport
201.15.3.5.102 Shock and vibration for transport
202.6.2.101 Electrosurgery interference recovery |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 80601-2-30:2018 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
[Exception]
201.15.3.5.101 Shock and vibration (robustness)
202 Electromagnetic disturbances – Requirements and tests |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-34:2011 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
[Exception]
201.12.1.101.2 Accuracy of systolic and diastolic pressure
201.12.1.101.3 Frequency response |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-36:2014 |
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-37:2007+A1:2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
[Exception]
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS (IPX1) |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| IEC 60601-2-41:2021 |
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
[Exception]
201.10.5.103.3 Chromaticity
201.10.5.103.4 Colour rendering
201.10.6 Infrared radiation
201.10.7 Ultraviolet radiation
201.10.101 Broadband radiation |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Illuminance: Up to 180 000 lx
Distance: 5.5 m |
소재지 |
| IEC 60601-2-43:2010+A1:2017 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
[Exception]
201.11.6.5.103 ENCLOSURES |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
X-ray: 0.000 μSv ~ 9999 Sv
Distance: 5.5 m |
소재지 |
| IEC 60601-2-2:2017 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
[Exception]
201.15.101.5 NE thermal performance |
Single phase: Max. 300 V a.c.
Three phase: Max. 600 V a.c.
Temperature: (0 ~ 200) ℃
Dielectric strength: AC/DC 10 kV
Temperature & Humidity:
(-40 ~ 120) ℃, Max. 93 % R.H. |
소재지 |
| ▶ 전자기적합성 |
| EN ISO 80601-2-74:2021 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-43:2010+A1:2018+A2:2020 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-43:2010+A1:2018 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 60601-2-41:2021 |
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-37:2008+A11:2011+A1:2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-36:2015 |
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-34:2014 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-30:2019 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 60601-2-28:2019 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-27:2014 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-26:2020+A1:2024 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-26:2020 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-25:2015 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-24:2015 |
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 60601-2-22:2020 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-18:2015 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-12:2023 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-10:2015+A1:2016 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-5:2015 |
Medical electrical equipment - Part 2-5: particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-4:2011+A1:2019 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-4:2011 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 60601-2-2:2018 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-1-2:2007 |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard : Electromagnetic disturbances - Requirements and tests |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-1-2:2015 |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard : Electromagnetic disturbances - Requirements and tests |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-1-2:2015/A1:2021 |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard : Electromagnetic disturbances - Requirements and tests |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
Radiated fields in close proximity: 9 ㎑ ~ 13.56 ㎒
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 60601-2-43:2023 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-44:2009+A11:2011+A1:2012+A2:2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-77:2021+A1:2023 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-77:2021 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-78:2020 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-49:2018 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-24:2012 |
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-25:2011 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-26:2012 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-26:2019 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-26:2019+A1:2024 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-27:2011+CORR.1:2012 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-28:2010 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-28:2017 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-30:2009+A1:2013 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-30:2018 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-34:2011 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-36:2014 |
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-37:2007+A1:2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-41:2021 |
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-43:2010+A1:2017 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-43:2010+A1:2017+A2:2019 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-43:2022 |
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-22:2007+A1:2012 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-22:2007 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-22:2019 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| CISPR 14-2:2020 |
Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 2: Immunity - Product family standard |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓, 3 V/m
EFT/Burst: ± 1 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 230 ㎒, 3 V
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-57:2011 |
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-71:2018 |
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-65:2013+A1:2020+A2:2021 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-65:2013+A1:2020 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-63:2015+A1:2019+A2:2021 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-63:2015+A1:2019 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-63:2015 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-62:2015 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-61:2019 |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-60:2020 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-45:2011+A1:2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 60601-2-46:2019 |
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-47:2015 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 80601-2-49:2019 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-52:2010+A1:2015 |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-54:2009+A1:2015 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 60601-2-54:2009+A1:2015+A2:2019 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-55:2018 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratorygasmonitors |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-55:2018+A1:2023 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratorygasmonitors |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-56:2017+A1:2020 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-80:2019 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-87:2021 |
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-90:2021 |
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-71:2015 |
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-72:2015 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-72:2023 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-74:2021 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-77:2019 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-77:2019+A1:2023 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-78:2019 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-78:2019+A1:2024 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-79:2018 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-80:2018 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-87:2021 |
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-90:2021 |
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| CISPR 14-1:2020 |
Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
DP: 30 ㎒ ~ 300 ㎒
RE: 9 ㎑ ~ 6 ㎓ |
부속시설-1 |
| EN IEC 55014-1:2021 |
Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1: Emission |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
DP: 30 ㎒ ~ 300 ㎒
RE: 9 ㎑ ~ 6 ㎓ |
부속시설-1 |
| IEC 60601-2-63:2012 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-62:2013 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-46:2023 |
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-47:2012 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-49:2011 |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-65:2012+A1:2017+A2:2021 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-65:2012+A1:2017 |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-63:2012+A1:2017+A2:2021 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-1-2:2014+AMD1:2020 |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard : Electromagnetic disturbances - Requirements and tests |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
Radiated fields in close proximity: 9 ㎑ ~ 13.56 ㎒
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-1-2:2014 |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard : Electromagnetic disturbances - Requirements and tests |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-1-2:2007 |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard : Electromagnetic disturbances - Requirements and tests |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-2:2009+CORR.1:2014 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-2:2017 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-2:2017+A1:2023 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-4:2010 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-4:2010+A1:2018 |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-5:2009 |
Medical electrical equipment - Part 2-5: particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-10:2012+A1:2016 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-10:2012+A1:2016+A2:2023 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-12:2011 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-12:2020 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-12:2023 |
Medical electrical equipment - Part 2-12: Particular requirements for Basic safety and essential performance of critical care ventilators |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-18:2009 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-44:2009+A1:2012+A2:2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-45:2011+A1:2015 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-45:2011+A1:2015+A2:2022 |
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-63:2012+A1:2017 |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-72:2023 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61000-6-4:2019 |
Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission standard for industrial environments |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎑ ~ 6 ㎓ |
부속시설-1 |
| EN IEC 61000-6-3:2021 |
Electromagnetic compatibility (EMC) - Part 6-3: Generic standards - Emission standard for equipment in residential environments |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎑ ~ 6 ㎓ |
부속시설-1 |
| EN IEC 61000-6-2:2019 |
Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity for industrial environments |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓, 10 V/m
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61000-6-1:2019 |
Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity for residential, commercial and light-industrial environments |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓, 3 V/m
EFT/Burst: ± 1 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 3 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61000-6-4:2018 |
Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission standard for industrial environments |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎑ ~ 6 ㎓ |
부속시설-1 |
| IEC 61000-6-3:2020 |
Electromagnetic compatibility (EMC) - Part 6-3: Generic standards: Emission standard for residential |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎑ ~ 6 ㎓ |
부속시설-1 |
| IEC 61000-6-2:2016 |
Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity for industrial environments |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓,
max. 10 V/m
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 150 ㎑ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61000-6-1:2016 |
Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity standard for residential, commercial and light-industrial environments |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓, 3 V/m
EFT/Burst: ± 1 ㎸
Surge: ± 2 ㎸
CS: 150 ㎑ ~ 80 ㎒, 3 V
Magnetic field: 3 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-2-6:2021 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-2-5:2021 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-5: Particular requirements – Test configurations, operational conditions and performance criteria for field devices with field bus interfaces according to IEC 61784-1 |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-2-4:2021 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-4: Particular requirements – Test configurations, operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9 |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-2-3:2021 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-3: Particular requirements – Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal onditioning |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-2-2:2021 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-2: Particular requirements – Test configurations, operational conditions and performance criteria for portable testing, measuring and monitoring equipment used in low-voltage distribution systems |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-2-1:2021 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-1: Particular requirements – Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-1:2021 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| CISPR 11:2024 |
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓ |
부속시설-1 |
| CISPR 11:2015/AMD1:2016/AMD2:2019 |
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓ |
부속시설-1 |
| EN 55011:2016/A2:2021 |
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓ |
부속시설-1 |
| IEC 60601-2-54:2009+A1:2015 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-54:2009+A1:2015+A2:2018 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-54:2022 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-55:2011 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratory gas monitors |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-55:2018 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratory gas monitors |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-55:2018+A1:2023 |
Medical electrical equipment - Part2-55: Particular Requirements for Basic Safety and Essential Performance of respiratory gas monitors |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-56:2017 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-56:2017+A1:2018 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-57:2011 |
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 60601-2-57:2023 |
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-60:2012 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 80601-2-60:2019 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| ISO 80601-2-61:2017 |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN ISO 80601-2-79:2019 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 55035:2017/A1:2020 |
Electromagnetic compatibility of multimedia equipment -Immunity requirements |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 1 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 1 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61326-2-6:2020 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61326-2-5:2020 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-5: Particular requirements – Test configurations, operational conditions and performance criteria for field devices with field bus interfaces according to IEC 61784-1 |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61326-2-4:2020 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-4: Particular requirements – Test configurations, operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9 |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 61000-4-5:2014+A1:2017 |
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test |
1 phase equipment, ≤ 16 A
Max. Pulse Voltage: ± 7 ㎸ |
부속시설-1 |
| IEC 61000-4-5:2014+A1:2017 |
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test |
1 phase equipment, ≤ 16 A
Max. Pulse Voltage: ± 7 ㎸ |
부속시설-1 |
| EN 61000-4-4:2012 |
Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test |
1 phase equipment, ≤ 16 A
Max. Pulse Voltage: ± 5 ㎸ |
부속시설-1 |
| IEC 61000-4-4:2012 |
Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test |
1 phase equipment, ≤ 16 A
Max. Pulse Voltage: ± 5 ㎸ |
부속시설-1 |
| EN IEC 61000-4-3:2020 |
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test |
1 phase equipment, ≤ 16 A
RS: 80 ㎒ ~ 6 ㎓ |
부속시설-1 |
| IEC 61000-4-3:2020 |
Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency electromagnetic field immunity test |
1 phase equipment, ≤ 16 A
RS: 80 ㎒ ~ 6 ㎓ |
부속시설-1 |
| EN 61000-4-2:2009 |
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
1 phase equipment, ≤ 16 A
ESD: ± 30 ㎸ |
부속시설-1 |
| IEC 61000-4-2:2008 |
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
1 phase equipment, ≤ 16 A
ESD: ± 30 ㎸ |
부속시설-1 |
| ETSI EN 301 489-17 V3.2.6 (2023-06) |
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems |
1 phase equipment, ≤ 16 A
CE: 150 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 6 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT: ± 1 ㎸
Surge: ± 2 ㎸
CS: 150 ㎑ ~ 80 ㎒
V-dip: (0 ~ 100 ) % |
부속시설-1 |
| ETSI EN 301 489-3 V2.3.2 (2023-01) |
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz |
1 phase equipment, ≤ 16 A
CE: 150 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 6 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT: ± 1 ㎸
Surge: ± 2 ㎸
CS: 150 ㎑ ~ 80 ㎒
V-dip: (0 ~ 100 ) % |
부속시설-1 |
| ETSI EN 301 489-1 V2.2.3 (2019-11) |
Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements |
1 phase equipment, ≤ 16 A
CE: 150 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 6 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT: ± 1 ㎸
Surge: ± 2 ㎸
CS: 150 ㎑ ~ 80 ㎒
V-dip: (0 ~ 100 ) % |
부속시설-1 |
| ETSI EN 301 489-1 V2.1.1 (2017-02) |
Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements |
1 phase equipment, ≤ 16 A
CE: 150 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 6 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT: ± 1 ㎸
Surge: ± 2 ㎸
CS: 150 ㎑ ~ 80 ㎒
V-dip: (0 ~ 100 ) % |
부속시설-1 |
| EN 61000-3-3:2013+A2:2021 |
Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection |
1 phase equipment, ≤ 16 A |
부속시설-1 |
| IEC 61000-3-3:2013/A1:2017+A2:2021 |
Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection |
1 phase equipment, ≤ 16 A |
부속시설-1 |
| EN IEC 55014-2:2021 |
Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 2: Immunity - Product family standard |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓, 3 V/m
EFT/Burst: ± 1 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 230 ㎒, 3 V
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61000-4-6:2023 |
Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
1 phase equipment, ≤ 16 A
CS: 150 ㎑ ~ 230 ㎒: 10 V |
부속시설-1 |
| EN IEC 61000-4-6:2023 |
Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
1 phase equipment, ≤ 16 A
CS: 150 ㎑ ~ 230 ㎒: 10 V |
부속시설-1 |
| IEC 61000-4-8:2009 |
Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
1 phase equipment, ≤ 16 A
100 A / Continuos |
부속시설-1 |
| IEC 61326-2-3:2020 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-3: Particular requirements – Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61326-2-2:2020 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-2: Particular requirements – Test configurations, operational conditions and performance criteria for portable testing, measuring and monitoring equipment used in low-voltage distribution systems |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61326-2-1:2020 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-1: Particular requirements – Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61326-1:2020 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61000-3-2:2018+A1:2020 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
1 phase equipment, ≤ 16 A |
부속시설-1 |
| EN IEC 61000-3-2:2019 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
1 phase equipment, ≤ 16 A |
부속시설-1 |
| EN IEC 61000-3-2:2019/A1:2021 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
1 phase equipment, ≤ 16 A |
부속시설-1 |
| CISPR 35:2016 |
Electromagnetic compatibility of multimedia equipment - Immunity requirements |
1 phase equipment, ≤ 16 A
ESD: ± 8 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 1 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 3 V
Magnetic field: 1 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 55032:2015/A1:2020 |
Electromagnetic compatibility of multimedia equipment - Emission requirements |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓ |
부속시설-1 |
| CISPR 32:2015/AMD1:2019 |
Electromagnetic compatibility of multimedia equipment - Emission requirements |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 9 ㎒ ~ 18 ㎓ |
부속시설-1 |
| EN 61000-4-39:2017 |
Electromagnetic compatibility (EMC) - Part 4-39: Testing and measurement techniques - Radiated fields in close proximity - Immunity test |
1 phase equipment, ≤ 16 A
Radiated fields in close proximity:
9 ㎑ ~ 13.56 ㎒ |
부속시설-1 |
| IEC 61000-4-39:2017 |
Electromagnetic compatibility (EMC) - Part 4-39: Testing and measurement techniques - Radiated fields in close proximity - Immunity test |
1 phase equipment, ≤ 16 A
Radiated fields in close proximity:
9 ㎑ ~ 13.56 ㎒ |
부속시설-1 |
| EN IEC 61000-4-11:2020 |
Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase |
1 phase equipment, ≤ 16 A
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61000-4-11:2020 |
Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests for equipment with input current up to 16 A per phase |
1 phase equipment, ≤ 16 A
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN 61000-4-8:2010 |
Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
1 phase equipment, ≤ 16 A
100 A / Continuos |
부속시설-1 |
| IEC 60601-2-52:2009+A1:2015 |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
1 phase equipment, ≤ 16 A
CE: 0.15 ㎒ ~ 30 ㎒
RE: 9 ㎑ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| IEC 61326-2-6:2025 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
| EN IEC 61326-2-6:2025 |
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment |
1 phase equipment, ≤ 16 A
CE: 9 ㎑ ~ 30 ㎒
RE: 30 ㎒ ~ 18 ㎓
ESD: ± 15 ㎸
RS: 80 ㎒ ~ 6 ㎓
EFT/Burst: ± 2 ㎸
Surge: ± 2 ㎸
CS: 0.15 ㎒ ~ 80 ㎒, 10 V
Magnetic field: 30 A/m
V-dip: (0 ~ 100) % |
부속시설-1 |
