| ▶ 의료기기 |
| 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 |
Applied temperature:
(-40 ~ 125) ℃
Applied humidity: 95 % R.H.
Measuring humidity: 95 % R.H.
Drop height: (0 ~ 1 200) mm
Sound level: 94 dB
Frequency: (10 ~ 2 000) Hz
Accelator: (1 ~ 100) m/s²
|
소재지 |
| EN 60601-1-3:2008+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 |
Measuring Tube Voltage:
(40 ~ 150) kVp
Measuring Tube Current:
Max. 1 500 mA
Measuring mAs:
Max. 9 999 mAs
Measuring Dose:
2 nGy ~ 559 Gy
Measuring frequency: 1 GHz
Measuring current: 20 A
Measuring distance: 1 000 mm |
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 |
| EN 60601-1-8:2007+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 |
Measuring frequency: 1 GHz
Measuring illumination:
(100 ~ 1 000) lx
Sound level: 94 dB |
소재지 |
| EN 60601-1:2006+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
8.9.1.7 Material groups classification
9.5.2 Cathode ray tubes
10.3 Microwave radiation
10.4 Lasers
11.2.2 ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS
11.2.3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
13.2.13.03 ME EQUIPMENT with motors b)
15.4.2 Temperature and over load control devices
15.4.2.1 Application f) - Requirement for Positive temperature coefficient devices (PTC’s)
15.4.3.4 Lithium batteries
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures
Annex L (normative) Insulated winding wires for use without inter leaved insulation |
Power supply:
single phase, three phase
Applied voltage:
400 V a.c. / 300 V d.c.
Measuring voltage:
1 000 V a.c. / 1 000 V d.c.
Applied current: 15 A
Measuring current: 20 A
Measuring frequency: 1 GHz
Measuring power: 4 800 W
Measuring distance: 1 000 mm
Applied temperature:
(-40 ~ 125) °C
Measuring temperature: 200 °C
Measuring resistance: 10 MΩ
Measuring capacitance: 1 μF
Applied force: 2 500 N
Measuring time: 1/100 s
Applied humidity: 95 % R.H.
Measuring humidity: 95 % R.H.
Measuring angle: 360°
Measuring pressure: 6 MPa
Measuring torque: 137 N·m
Measuring illumination:
(100 ~ 1 000) lx
Sound Level: 94 dB |
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 |
Applied voltage:
400 V a.c. / 300 V d.c.
Measuring voltage:
1 000 V a.c. / 1 000 V d.c.
Applied current: 15 A
Measuring current: 20 A
Measuring frequency: 1 GHz
Measuring resistance: 10 MΩ |
소재지 |
| EN 60601-2-18:2015 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
Measurement power:
(1 ~ 300) W
Measurement current:
(23 ~ 1 704) mA
Applied resistance:
(10 ~ 5 200) Ω |
소재지 |
| EN 60601-2-22:2013 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
Measuring frequency: 1 GHz
Applied force: 2 500 N
Laser power: Max. 49.6 W
Laser wavelength:
Max. 1 080 nm |
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 |
Weight: (0 ~ 200) g
Pressure Tests: 275 kPa
Flow Tests: Max. 830 ㎖/hr
Applied force: 199 N
Sound Level: 94 dB |
소재지 |
| EN 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]
201.15.101.6 NE contract impedance |
Measurement power:
(1 ~ 300) W
Measurement current :
(23 ~ 1 704) mA
Applied resistance :
(10 ~ 5 200) Ω |
소재지 |
| EN 80601-2-30:2019 |
Medical electrical equipment － Part 2-30:
Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
Measuring pressure:
(0.00 ~ 53.33) kPa
Frequency: (10 ~ 5 000) Hz
Accelator: (3 ~ 100) m/s²
Measuring temperature: 200 ℃
Applied humidity: 95 % R.H.
Measuring humidity: 95 % R.H. |
소재지 |
| IEC 60601-1-11:2015+AMD: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 |
Applied temperature:
(-40 ~ 125) ℃
Applied humidity: 95 % R.H.
Measuring humidity: 95 % R.H.
Drop height: (0 ~ 1 200) mm
Sound level: 94 dB
Frequency: (10 ~ 2 000) Hz
Accelator: (1 ~ 100) m/s²
|
소재지 |
| IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
Measuring Tube
Voltage:
(40 ~ 150) kVp
Measuring Tube
Current:
Max. 1 500 mA
Measuring mAs:
Max. 9 999 mAs
Measuring Dose:
2 nGy ~ 559 Gy
Measuring frequency: 1 GHz
Measuring current: 20 A
Measuring distance:
1 000 mm |
소재지 |
| IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
- |
소재지 |
| IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 |
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 |
Measuring frequency:
1 GHz
Measuring illumination:
(100 ~ 1 000) lx
Sound level : 94 dB |
소재지 |
| IEC 60601-1:2005+AMD1:2012+AMD2:2020 |
Medical electrical equipment － Part 1: General requirements for basic safety and essential performance
[Exception]
8.8.4.2 Resistance to environmental stress
8.9.1.7 Material groups classification
9.5.2 Cathode ray tubes
10.3 Microwave radiation
10.4 Lasers
11.2.2 ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS
11.2.3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
13.2.13.3 ME EQUIPMENT with motors b)
15.4.2 Temperature and over load control devices
15.4.2.1 Application f) - Requirement for Positive temperature coefficient devices (PTC’s)
15.4.3.4 Lithium batteries
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures
Annex L (normative) Insulated winding wires for use without inter leaved insulation |
Power supply:
single phase, three phase
Applied voltage:
400 V a.c. / 300 V d.c.
Measuring voltage:
1 000 Va.c. / 1 000 V d.c.
Applied current: 15 A
Measuring current: 20 A
Measuring frequency: 1 GHz
Measuring power: 4 800 W
Measuring distance: 1 000 mm
Applied temperature:
(-40 ~ 125) °C
Measuring temperature: 200 °C
Measuring resistance: 10 MΩ
Measuring capacitance: 1 μF
Applied force: 2 500 N
Measuring time: 1/100 s
Applied humidity: 95 % R.H.
Measuring humidity: 95 % R.H.
Measuring angle: 360°
Measuring pressure: 6 MPa
Measuring torque: 137 N·m
Measuring illumination:
(100 ~ 1 000) lx
Sound Level: 94 dB |
소재지 |
| IEC 60601-2-10:2012+AMD1:2016+AMD2:2023 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
Applied voltage:
400 V a.c. / 300 V d.c.
Measuring voltage:
1 000 V a.c. / 1 000 V d.c.
Applied current: 15 A
Measuring current: 20 A
Measuring frequency: 1 GHz
Measuring resistance: 10 MΩ |
소재지 |
| IEC 60601-2-18:2009 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
Measurement power:
(1 ~ 300) W
Measurement current :
(23 ~ 1 704) mA
Applied resistance :
(10 ~ 5 200) Ω |
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 |
Measuring frequency: 1 GHz
Applied force: 2 500 N
Laser power: Max. 49.6 W
Laser wavelength:
Max. 1 080 nm |
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 |
Weight: (0 ~ 200) g
Pressure Tests: 275 kPa
Flow Tests: Max. 830 ㎖/hr
Applied force: 199 N
Sound Level: 94 dB |
소재지 |
| IEC 60601-2-2:2017+AMD1:2023 |
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]
201.15.101.6 NE contract impedance |
Measurement power:
(1 ~ 300) W
Measurement current:
(23 ~ 1 704) mA
Applied resistance:
(10 ~ 5 200) Ω |
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 |
Measuring pressure:
(0.00 ~ 53.33) kPa
Frequency:
(10 ~ 5 000) Hz
Accelator: (3 ~ 100) m/s²
Measuring temperature: 200 ℃
Applied humidity: 95 % R.H.
Measuring humidity: 95 % R.H. |
소재지 |
| 식품의약품안전처 고시 제2020-29호 |
[별표 1] 의료기기의 전기·기계적 안전에 관한공통기준규격 및 시험방법
[제외]
8.8.4.2 환경 스트레스에 대한 내성
8.9.1.7 재료그룹 분류
9.5.2 음극선관(CRT)
10.3마이크로파 방사선
10.4 레이저
11.2.2 산소과밀환경에서 사용하는 ME기기 및 ME시스템
11.2.3 ME기기 및 ME시스템에 따른 산소과밀환경과 관련한 단일고장상태
11.6.7 ME기기 및 ME시스템의 멸균
13.2.13.3 모터를 가지는 ME기기 b)
15.4.2온도 및 과부하 제어장치
15.4.2.1 적용 f)
15.4.3.4 리튬 전지
부속서 G 가연성 마취제의 점화 위해요인에 대한 보호
부속서 L 삽입절연 없이 사용하는 절연권선 와이어 |
Power supply:
single phase, three phase
Applied voltage:
400 V a.c. / 300 V d.c.
Measuring voltage:
1 000 V a.c. / 1 000 V d.c.
Applied current: 15 A
Measuring current: 20 A
Measuring frequency: 1 GHz
Measuring power: 4 800 W
Measuring distance: 1 000 mm
Applied temperature:
(-40 ~ 125) °C
Measuring temperature: 200 °C
Measuring resistance: 10 MΩ
Measuring capacitance: 1 μF
Applied force: 2 500 N
Measuring time: 1/100 s
Applied humidity: 95 % R.H.
Measuring humidity: 95 % R.H.
Measuring angle: 360°
Measuring pressure: 6 MPa
Measuring torque: 137 N·m
Measuring illumination:
(100 ~ 1 000) lx
Sound Level: 94 dB |
소재지 |
| ▶ 전자기적합성 |
| CISPR 11:2015+AMD1:2016+AMD2:2019 |
Industrial, scientific and medical equipment- Radio-frequency disturbance characteristics - Limits and methods of measurement |
Voltage: Max. 440 V
Current: Max. 100 A
Measuring distance:
Max. 10 m
CE Frequency Range:
9 kHz ~ 30 MHz
RE Frequency Range:
9 kHz ~ 18 GHz |
소재지 |
| CISPR 14-1:2020 |
Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus - Part 1 : Emission |
Voltage: Max. 440 V
Current: Max.100 A
Measuringdistance:Max.10 m
DisturbanceVoltage/Current/PowerFrequencyRange:
9 kHz ~ 30 MHz
RadiatedDisturbance/MagneticFieldFrequencyRange:
9 kHz ~ 1 GHz |
소재지 |
| CISPR 14-2:2020 |
Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus
- Part 2: Immunity - Product family standard |
Voltage: Max. 440 V
Current: Max. 100 A
RS: Max. 3 V/m
CS: Max. 3 Vrms
ESD: Max. ±8 kV
Burst: Max. ±1 kV
Surge: Max. ±2 kV
V-Dip: (0 ~ 100) % |
소재지 |
| CISPR 32:2015 +AMD1:2019 |
Electromagnetic compatibility of multimedia equipment – Emission requirements |
Voltage: Max. 440 V
Current: Max. 100 A
Measuring distance:
Max.10 m
CE Freuqency Range:
150 kHz ~ 30 MHz
RE Freuqency Range:
30 MHz ~ 6 GHz |
소재지 |
| CISPR 35:2016 |
Electromagnetic compatibility of multimedia equipment – Immunity requirements |
Voltage: Max. 440 V
Current: Max. 100 A
RS: Max. 3 V/m
CS: Max. 3 Vrms
ESD: Max. ±8 kV
Burst: Max. ±1 kV
Surge: Max. ±4 kV
MF: Max. 1 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| 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 |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 30 V/m
CS: Max. 10 Vrms
ESD: Max. ±15 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 30 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| IEC 60601-2-10:2012+A1:2016+AMD2:2023 CSV |
Medical electrical equipment
- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
․ Section 202 : Electromagnetic disturbances - Requirements and tests |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| IEC 60601-2-18:2009 |
Medical electrical equipment
- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
․ Section 202 : Electromagnetic compatibility - Requirements and tests |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
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
(Section) 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
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
․ Section 202 : Electromagnetic compatibility - Requirements and tests |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| IEC 60601-2-2:2017+AMD1:2023 CSV |
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
․ Section 202 : Electromagnetic disturbances - Requirements and tests |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| IEC 60601-2-5:2009 |
Medical electrical equipment
- Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physio therapy equipment
․ Section 202 : Electromagnetic compatibility - Requirements and tests |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| IEC 61000-3-11:2017 |
Electromagnetic compatibility (EMC)
- Part 3-11: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems - Equipment with rated current ≤ 75 A and subject to conditional connection |
Voltage: Max. 440 V
Current: Min. 16 A,
Max. 75 A |
소재지 |
| IEC 61000-3-12:2011+AMD1:2021 |
Electromagnetic compatibility (EMC)
- Part 3-12: Limits - Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16 A and ≤ 75 A per phase |
Voltage: Max. 440 V
Current: Min. 16 A,
Max. 75 A |
소재지 |
| IEC 61000-3-2:2018/AMD1:2024 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
Voltage: Max. 440 V
Current: Max. 16 A |
소재지 |
| IEC 61000-3-3:2013/AMD2:2021 |
Electromagnetic compatibility (EMC)-Part3-3:Limits-Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16A per phase and not subject to conditional connection |
Voltage: Max. 440 V
Current: Max. 16 A |
소재지 |
| 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 |
Voltage: Max. 440 V
Current: Max. 16 A
Test Levels: (0 ~ 100) % |
소재지 |
| IEC 61000-4-2:2008 |
Electromagnetic compatibility (EMC)
- Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
Test Levels: Max. 15 kV |
소재지 |
| IEC 61000-4-34:2005+A1:2009 |
Electromagnetic compatibility (EMC)
- Part 4-34: Testing and measurement techniques
- Voltage dips, short interruptions and voltage variations immunity tests for equipment with mains current more than 16 A per phase |
Voltage: Max. 440 V
Current: Max. 75 A
Test Levels: (0 ~ 100) % |
소재지 |
| IEC 61000-4-3:2020 |
Electromagnetic compatibility (EMC)
- Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
Frequency Range:
80 MHz ~ 6 GHz
Test Distance: Max. 3 m
Field Strength: Max. 30 V/m |
소재지 |
| IEC 61000-4-4:2012 |
Electromagnetic compatibility (EMC)
- Part 4-4: Testing and measurement techniques
- Electrical fast transient/burst immunity test |
Voltage: Max. 440 V
Current: Max. 75 A
Test Levels: Max. ±4 kV |
소재지 |
| IEC 61000-4-5:2014 +A1:2017 |
Electromagnetic compatibility (EMC)
- Part 4-5: Testing and measurement techniques - Surge immunity test |
Voltage: Max. 440 V
Current: Max. 75 A
Test Levels: Max. ±4 kV |
소재지 |
| IEC 61000-4-6:2023 |
Electromagnetic compatibility (EMC)
- Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
Frequency Range:
(0.15 ~ 80) MHz
Test Levels: Max. 10 Vrms |
소재지 |
| IEC 61000-4-8:2009 |
Electromagnetic compatibility (EMC)
- Part 4-8: Testing and measurement technique
- Power frequency magnetic field immunity test |
Power Frequency:
50 Hz, 60 Hz
Test Levels: Max. 30 A/m |
소재지 |
| IEC 61326-1:2020 |
Electrical equipment for measurement, control and laboratory use - EMC requirements
- Part 1: General requirements |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±4 kV
Surge: Max. ±4 kV
MF: Max. 3 A/m
V-Dip:(0 ~ 100) % |
소재지 |
| 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 |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±4 kV
Surge: Max. ±4 kV
MF: Max. 3 A/m
V-Dip:(0 ~ 100) % |
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
․ Section 202 : Electromagnetic compatibility - Requirements and tests |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 20 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| ISO 15197:2013 |
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
․ Section 5.4 : Electromagnetic compatibility |
Voltage: Max. 440 V
Current: Max. 100 A
Test Distance: Max. 10 m
CE: 150 kHz ~ 30 MHz
RE: 30 MHz ~ 18 GHz
RS: Max. 10 V/m
CS: Max. 10 Vrms
ESD: Max. ±8 kV
Burst: Max. ±2 kV
Surge: Max. ±2 kV
MF: Max. 3 A/m
V-Dip: (0 ~ 100) % |
소재지 |
| KS C 9610-3-11 :2023 |
전자파적합성(EMC) - 제3-11부: 허용기준 – 공공 저압 배전망에서의 전압변동 및 플리커에 대한 허용기준(상당 정격전류 75 A 이하와 조건부 연결 기기) |
전압: Max. 440 V
전류: Min. 16 A,
Max. 75 A |
소재지 |
| KS C 9610-3-12 :2023 |
전자파적합성(EMC) - 제3-12부: 허용기준 - 공공 저압 배전망에 연결된 기기에서 발생하는 고조파 전류의 허용기준 (16 A < 상당 입력전류 ≤75 A) |
전압: Max. 440 V
전류: Min. 16 A,
Max. 75 A |
소재지 |
| KS C 9610-3-2 :2023 |
전자파적합성(EMC) - 제3-2부: 허용 기준 – 고조파 전류의 허용기준(상당 입력 전류 16 A 이하기기) |
전압: Max. 440 V
전류: Max. 16 A |
소재지 |
| KS C 9610-3-3 :2023 |
전자파적합성(EMC) - 제3-3부: 허용 기준 – 공공저압 배전망에 사용하는 기기의 플리커와 전압변동에 대한 허용기준(상당 16 A 이하 기기) |
전압: Max. 440 V
전류: Max. 16 A |
소재지 |
| KS C 9610-4-11 :2020 |
전자파적합성(EMC) - 제4-11부: 시험 및 측정기술 – 전압 강하, 순간 정전, 전압 변동 내성 시험 |
전압: Max. 440 V
전류: Max. 16 A
시험 레벨: (0 ~ 100) % |
소재지 |
| KS C 9610-4-2 :2017 |
전자파적합성(EMC) - 제4-2부: 시험 및 측정기술 - 정전기 방전 내성 시험 |
시험 레벨: Max. 15 kV |
소재지 |
| KS C 9610-4-3 :2017 |
전자파적합성(EMC) - 제4-3부: 시험 및 측정 기술 - 방사성 RF 전자기장 내성 시험 |
주파수 범위:
80 MHz ~ 6 GHz
적용거리: Max. 3 m
전계강도: Max. 30 V/m |
소재지 |
| KS C 9610-4-4:2020 |
전자파적합성(EMC) - 제4-4부: 시험 및 측정 기술 - 전기적 빠른 과도현상, 버스트 내성 시험 |
전압: Max. 440 V
전류: Max. 75 A
시험 레벨: Max. ±4 kV |
소재지 |
| KS C 9610-4-5 :2023 |
전자파적합성(EMC) - 제4-5부: 시험 및 측정 기술 - 서지 내성 시험 |
전압: Max. 440 V
전류: Max. 75 A
시험 레벨: Max. ±4 kV |
소재지 |
| KS C 9610-4-6 :2020 |
전자파적합성(EMC) - 제4-6부: 시험 및 측정 기술 – 전도성 RF 전자기장 내성 시험 |
주파수 범위:
(0.15 ~ 80) MHz
시험 레벨: Max. 10 Vrms |
소재지 |
| KS C 9610-4-8 :2017 |
전자파적합성(EMC) - 제4-8부: 시험 및 측정기술 - 전원 주파수 자기장 내성 시험 |
전원 주파수: 60 Hz
시험 레벨: Max. 30 A/m |
소재지 |
| KS C 9811:2019 |
산업 과학 의료용(ISM) 기기 - 무선주파수 방해 특성 - 허용기준 및 측정방법 |
전압: Max. 440 V
전류: Max. 100 A
측정거리: Max. 10 m
전원포트 방해전압 주파수 범위: 9 kHz ~ 30 MHz
방사성 방해 주파수 범위:
9 kHz ~ 18 GHz |
소재지 |
| KS C 9814-1:2022 |
전자파적합성(EMC) - 가정용 전기기기, 전동 공구 및 유사기기의 요구사항 - 제1부: 방출 |
전압: Max. 440V
전류: Max. 100A
측정거리: Max. 10 m
방해 전압/전류/전력 주파수 범위: 9 kHz ~ 30 MHz
방사성 방해/자기장 주파수 범위: 9 kHz ~ 1 GHz |
소재지 |
| KS C 9814-2:2022 |
전자파적합성(EMC) - 가정용 전기기기, 전동 공구 및 유사기기의 요구사항 - 제2부: 내성 |
전압: Max. 440 V
전류: Max. 100 A
방사성RF 전자기장내성: Max. 3 V/m
전도성RF 전자기장내성:
Max. 3 Vrms
정전기방전: Max. ±8 kV
버스트내성: Max. ±1 kV
서지: Max. ±2 kV
전압강하: (0 ~ 100) % |
소재지 |
| KS C 9832:2024 |
멀티미디어 기기 전자파 장해 시험방법 |
전압: Max. 440 V
전류: Max. 100 A
측정거리: Max. 10 m
주전원 포트 주파수 범위: 150 kHz ~ 30 MHz
복사성 방출 주파수 범위:
30 MHz ~ 6 GHz |
소재지 |
| KS C 9835:2019 |
멀티미디어 기기 전자파 내성 시험방법 |
전압: Max. 440 V
전류: Max. 100 A
방사성 RF 전자기장: Max. 3 V/m
전도성 RF 전자기장: Max. 3 Vrms
정전기 방전: Max. ±8 kV
버스트: Max. ±1 kV
서지: Max. ±4 kV
전원주파수 자기장: Max. 1 A/m
전압강하와순간정전: (0 ~ 100) % |
소재지 |
| KS C IEC 60601-1-2:2020 |
의료용 전기기기 – 제1-2부: 기본안전 및 필수성능에 관한 일반 요구사항 – 보조표준: 전자파 방해 – 요구사항 및 시험 |
전압: Max. 440 V
전류: Max. 100 A
측정거리: Max. 10 m
전원포트 방해전압 주파수 범위: 150 kHz ~ 30 MHz
방사성 방해 주파수 범위:
30 MHz ~ 18 GHz
방사성 RF 전자기장: Max. 10 V/m
전도성 RF 전자기장: Max. 10 Vrms
정전기방전: Max. ±15 kV
버스트: Max. ±2 kV
서지: Max. ±2 kV
전원주파수자기장: Max. 30 A/m
전압강하, 순간정전 및 전압변동:
(0 ~ 100) % |
소재지 |
| 식품의약품안전처 고시 제2020-29호 |
의료기기의 전자파안전에 관한 공통기준규격 |
전압: Max. 440 V
전류: Max. 100 A
측정거리: Max. 10 m
단자 장해전압 주파수 범위: 150 kHz ~ 30 MHz
전자파방사 장해 주파수 범위: 30 MHz ~ 18 GHz
방사성 RF 전자기장: Max. 10 V/m
RF 전기장에 의해서 유도되는 전도성 장해: Max. 10 Vrms
정전기방전: Max. ±8 kV
버스트: Max. ±2 kV
서지: Max. ±2 kV
전원주파수 자계: Max. 3 A/m
전압강하, 순시정전 및 전압변동: (0 ~ 100) % |
소재지 |
| ▶ 환경 및 신뢰성 |
| KS C IEC 60068-2-1:2007 |
환경 시험 - 제2-1부: 시험 - 시험 A: 내한성 시험 |
적용온도: (-40 ~ 5) ℃ |
소재지 |
| KS C IEC 60068-2-2:2007 |
환경 시험 - 제2-2부: 시험 - 시험 B: 내열성 시험 |
적용온도: (30 ~ 125) ℃ |
소재지 |
| KS C IEC 60068-2-30:2005 |
환경 시험 ㅡ 제 2-30부: 시험 ㅡ 시험 Db와 지침: 내습 사이클(12+12-h 사이클) |
적용온도: (25 ~ 55) ℃
적용습도: (45 ~ 95) % R.H. |
소재지 |
| KS C IEC 60068-2-64:2019 |
환경 시험 ㅡ 제2-64부: 시험 ㅡ 시험 Fh: 광대역 불규칙 진동 시험 및 지침 |
주파수: (10 ~ 2 000) Hz
가속도: (3 ~ 100) m/s² |
소재지 |
| KS C IEC 60068-2-6:2015 |
환경 시험 － 제2-6부 : 시험 － 시험 Fc : 진동(정현파) |
주파수: (10 ~ 2 000) Hz
가속도: (3 ~ 200) m/s² |
소재지 |
