| ▶ 의료기기 |
| IEC 60601-1:2005+AMD1:2012 |
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,
9.6.2.1 Audible acoustic energy,
10.1.2 ME EQUIPMENT Intended to produce diagnostic or therapeutic X-radiation,
10.3 Microwave radiation,
10.4 Lasers,
11.3 Constructional requirements for fire ENCLOSURES of ME EQUIPMENT
11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS,
12.3 ALARM SYSTEMS,
12.4.5 Diagnostic or therapeutic radiation,
15.4.2.1 f) The use of a THERMAL CUT-OUT or OVER-CURRENT RELEASE in the design shall not affect the safety of the ME EQUIPMENT,
15.4.3.4 Lithium batteries,
15.4.6 Actuating parts of controls of ME EQUIPMENT,
15.5.3 Construction of transformers used to provide separation as required by 8.5,
Annex G Protection against HAZARDS of ignition of flammable anaesthetic mixtures,
Annex L Insulated winding wires for use without interleaved insulation |
Applied voltage :
AC (0 ~ 264) V
DC (0 ~ 32) V
Measuring voltage :
AC (0 ~ 10) kV
DC (0 ~ 15) kV
Appllied current :
(5 ~ 25) A
Measuring current :
(0 ~ 100) A
Appllied frequency :
(45 ~ 1 000) Hz
Measuring frequency :
(0 ~ 10) MHz
Appllied temperature :
(0 ~ 150) ℃
Measuring temperature :
(0 ~ 200) ℃
Appllied humidity :
93 % R.H.
Measuring humidity :
93 % R.H.
Measuring power :
(60 ~ 2 400) W
Applied resistance :
(50 ~ 22 500) Ω
Measuring resistance :
(0 ~ 19) MΩ |
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,
9.6.2.1 Audible acoustic energy,
10.1.2 ME EQUIPMENT Intended to produce diagnostic or therapeutic X-radiation,
10.3 Microwave radiation,
10.4 Lasers,
11.3 Constructional requirements for fire ENCLOSURES of ME EQUIPMENT
11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics
11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS,
12.3 ALARM SYSTEMS,
12.4.5 Diagnostic or therapeutic radiation,
15.4.2.1 f) The use of a THERMAL CUT-OUT or OVER-CURRENT RELEASE in the design shall not affect the safety of the ME EQUIPMENT,
15.4.3.4 Lithium batteries,
15.4.6 Actuating parts of controls of ME EQUIPMENT,
15.5.3 Construction of transformers used to provide separation as required by 8.5,
Annex G Protection against HAZARDS of ignition of flammable anaesthetic mixtures,
Annex L Insulated winding wires for use without interleaved insulation |
Applied voltage :
AC (0 ~ 264) V
DC (0 ~ 32) V
Measuring voltage :
AC (0 ~ 10) kV
DC (0 ~ 15) kV
Appllied current :
(5 ~ 25) A
Measuring current :
(0 ~ 100) A
Appllied frequency :
(45 ~ 1 000) Hz
Measuring frequency :
(0 ~ 10) MHz
Appllied temperature :
(0 ~ 150) ℃
Measuring temperature :
(0 ~ 200) ℃
Appllied humidity :
93 % R.H.
Measuring humidity :
93 % R.H.
Measuring power :
(60 ~ 2 400) W
Applied resistance :
(50 ~ 22 500) Ω
Measuring resistance :
(0 ~ 19) MΩ |
소재지 |
| IEC 60601-2-10:2012+AMD1:2016 |
Medical electrical equipment - Part 2-10 : Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
Applied resistance :
(0 ~ 2) kΩ
Measuring voltage :
AC (0 ~ 1) kV
DC (0 ~ 15) kV
Measuring current :
(0 ~ 100) A
Measuring frequency :
(0 ~ 10) MHz
Measuring Time :
100 ns ~ 100 ms |
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 resistance :
(0 ~ 2) kΩ
Measuring voltage :
AC (0 ~ 1) kV
DC (0 ~ 15) kV
Measuring current :
(0 ~ 100) A
Measuring frequency :
(0 ~ 10) MHz
Measuring Time :
100 ns ~ 100 ms |
소재지 |
| IEC 60601-2-18:2009 |
Medical electrical equipment - Part 2-18 : Particular requirements for the basic safety and essential performance of endoscopic equipment
(exception)
201.11.101.2 Thermal and other HAZARDS from INTERCONNECTION CONDITIONS with HF SURGICAL EQUIPMENT |
Pressure range :
(0 ~ 1) MPa |
소재지 |
| IEC 60601-2-4:2010+AMD1:2018 |
Medical electrical equipment - Part 2-4 : Particular requirements for the basic safety and essential performance of cardiac defibrillators
(exception)
201.15.4.101 DEFIBRILLATOR ELECTRODES and their cables |
Measuring energy :
(0.1 ~ 600) J
Applied resistance :
(25 ~ 175) Ω
Measuring output voltage : (20 ~ 5 000) V
Measuring Charge time :
(0.1 ~ 100) s
Applied temperature :
(-30 ~ 65) ℃
Measuring ECG Amplitude : (0.05 ~ 5.0) mV
Measurig pacing pulse current : (4 ~ 250) mA
Measuring pacing pulse rate : (5 ~ 800) pulse per minute |
소재지 |
| ▶ 전자기적합성 |
| CISPR 11:2015+AMD1:2016+AMD2:2019 |
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
CE: 9 kHz ~ 30 MHz
RE: 150 kHz ~ 18 GHz
[Exception]
30 meter measurement |
소재지 |
| CISPR 11:2024 |
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
CE: 9 kHz ~ 30 MHz
RE: 150 kHz ~ 18 GHz
[Exception]
30 meter measurement |
소재지 |
| CISPR 32:2015+AMD1:2019 |
Electromagnetic compatibility of multimedia equipment - Emission requirements (Exception) Annex A_Table A.6, Table A.7, Table A.11, Table A.12, Table A.13 |
CE : 150 kHz ~ 30 MHz
RE : 30 MHz ~ 6 GHz |
소재지 |
| EN 55011:2016/A11:2020 |
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
CE: 9 kHz ~ 30 MHz
RE: 150 kHz ~ 18 GHz |
소재지 |
| EN 55035:2017+A11:2020 |
Electromagnetic compatibility of multimedia equipment - Immunity Requirements |
ESD : ±8 kV
RS : 80 MHz ~ 5 GHz, 3 V/m
EFT : ±1 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz ,3 V
MF : 1 A/m
V-dip : (0 ~ 100) % |
소재지 |
| 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 |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT : ±2 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz, 6 V
MF : 30 A/m
V-dip : (0 ~ 100) % |
소재지 |
| 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
(Exception)
8.11 Immunity to proximity magnetic fields |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT : ±2 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz, 6 V
MF : 30 A/m
V-dip : (0 ~ 100) % |
소재지 |
| EN 61000-3-2:2019 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
(Exception) 7.3 Limits for Class C equipment |
≤ 16 A(1Φ) |
소재지 |
| 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)
(Exception) 7.3 Limits for Class C equipment |
≤ 16 A(1Φ) |
소재지 |
| IEC 61000-3-2:2018+AMD1:2020+AMD2:2024 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
(Exception) 7.4 Limits for Class C equipment |
≤ 16 A(1Φ) |
소재지 |
| EN 61000-3-3:2013 |
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 |
≤ 16 A(1Φ) |
소재지 |
| EN 61000-3-3:2013/A1:2019 |
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 |
≤ 16 A(1Φ) |
소재지 |
| 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 |
≤ 16 A(1Φ) |
소재지 |
| EN 61000-4-2:2009 |
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques. Electrostatic discharge immunity test |
ESD : ±15 kV |
소재지 |
| EN IEC 61000-4-3:2020 |
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques. Radiated, radio-frequency, electromagnetic field immunity test |
80 MHz ~ 6 GHz |
소재지 |
| EN 61000-4-4:2012 |
Electromagnetic compatibility (EMC) Part 4-4: Testing and measurement techniques. Electrical fast transient/burst immunity test |
±4.0 kV |
소재지 |
| EN 61000-4-5:2014 |
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test |
±4.0 kV |
소재지 |
| EN 61000-4-5:2014/AMD1:2017 |
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test |
±4.0 kV |
소재지 |
| EN 61000-4-6:2014 |
Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
150 kHz ~ 230 MHz |
소재지 |
| BS 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 |
150 kHz ~ 230 MHz |
소재지 |
| EN 61000-4-8:2010 |
Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
40 A/Continuous
330 A/Short |
소재지 |
| 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 |
≤ 16 A |
소재지 |
| EN 61000-6-1:2019 |
Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity for residential, commercial and light-industrial environments |
ESD : ±8 kV
RS : 80 MHz ~ 6 GHz, 3 V/m
EFT : ±1 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz, 3 V
MF : 3 A/m
V-dip : (0 ~ 100) % |
소재지 |
| EN 61000-6-2:2019 |
Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity for industrial environments |
ESD : ±8 kV
RS : 80 MHz ~ 2.7 GHz, 10 V/m
EFT : ±2 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz, 10 V
MF : 30 A/m
V-dip : (0 ~ 100 ) % |
소재지 |
| EN 61000-6-3:2007+A1:2011/AC:2012 |
Electromagnetic compatibility (EMC) - Part 6-3: Generic standards - Emission standard for residential, commercial and light-industrial environments |
CE : 150 kHz ~ 30 MHz
RE : 30 MHz ~ 6 GHz |
소재지 |
| EN 61000-6-4:2019 |
Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission standard for industrial environments |
CE : 150 kHz ~ 30 MHz
RE : 30 MHz ~ 6 GHz |
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
[Exception]
8.11 Immunity to proximity magnetic fields |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT : ±2 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz, 6 V
MF : 30 A/m
V-dip : (0 ~ 100) % |
소재지 |
| IEC 61000-3-2:2018/AMD1:2020 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
(Exception) 7.4 Limits for Class C equipment |
≤ 16 A(1Φ) |
소재지 |
| IEC 61000-3-2:2018 |
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
(Exception) 7.4 Limits for Class C equipment |
≤ 16 A(1Φ) |
소재지 |
| IEC 61000-3-3:2013/AMD2:2021 |
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 |
≤ 16 A(1Φ) |
소재지 |
| IEC 61000-3-3:2013+AMD1:2017 |
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 |
≤ 16 A(1Φ) |
소재지 |
| IEC 61000-3-3:2013 |
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 |
≤ 16 A(1Φ) |
소재지 |
| IEC 61000-4-2:2008 |
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
ESD : ±15 kV |
소재지 |
| IEC 61000-4-4:2012 |
Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test |
±4.0 kV |
소재지 |
| IEC 61000-4-5:2014 |
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test |
±4.0 kV |
소재지 |
| IEC 61000-4-5:2014+AMD1:2017 |
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test |
±4.0 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 |
150 kHz ~ 230 MHz |
소재지 |
| IEC 61000-4-8:2009 |
Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
40 A/Continuous
330 A/Short |
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 |
≤ 16 A |
소재지 |
| IEC 61000-6-1:2016 |
Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity for residential, commercial and light-industrial environments |
ESD : ±8 kV
RS : 80 MHz ~ 6 GHz, 3 V/m
EFT : ±1 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz, 3 V
MF : 3 A/m
V-dip : (0 ~ 100) % |
소재지 |
| IEC 61000-6-2:2016 |
Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity standard for industrial environments |
ESD : ±8 kV
RS : 80 MHz ~ 6 GHz, 10 V/m
EFT : ±2 kV
Surge : ±2 kV
CS : 150 kHz ~ 80 MHz ,10 V
MF : 30 A/m
V-dip : (0 ~ 100) % |
소재지 |
| IEC 61000-6-4:2018 |
Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission standard for industrial environments |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz |
소재지 |
| MIL-STD-461E: 1999 |
DEPARTMENT OF DEFENSE INTERFACE STANDARD REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
5.4 CE101, conducted emissions, power leads, 30 Hz to 10 kHz.
5.5 CE102, conducted emissions, power leads, 10 kHz to 10 MHz.
5.7 CS101, conducted susceptibility, power leads, 30 Hz to 150 kHz.
5.12 CS114, conducted susceptibility, bulk cable injection, 10 kHz to 200 MHz.
5.13 CS115, Conducted susceptibility, bulk cable injection, impulse excitation.
5.14 CS116, conducted susceptibility, damped sinusoidal transients, cables and power leads, 10 kHz to 100 MHz.
5.15 RE101, Radiated emissions, magnetic field, 30 Hz to 100 kHz.
5.16 RE102, radiated emissions, electric field, 10 kHz to 18 GHz.
5.18 RS101, radiated susceptibility, magnetic field, 30 Hz to 100 kHz.
5.19 RS103, radiated susceptibility, electric field, 2 MHz to 40 GHz.
(Exception)
5.18.4 RS101 alternative test procedures – AC Helmholtz coil.
5.19.4 RS103 alternative test procedures – reverberation chamber (mode-tuned). |
CE101 : 30 Hz ~ 10 kHz
CE102 : 10 kHz ~ 10 MHz
CS101 : 30 Hz ~ 150 kHz
CS114 : 10 kHz ~ 200 MHz
CS115 : 5 A
CS116 : 10 kHz ~ 100 MHz
RE101 : 30 Hz ~ 100 kHz
RE102 : 10 kHz ~ 18 GHz
RS101 : 30 Hz ~ 100 kHz
RS103 : 2 MHz ~ 18 GHz, 60 V/m |
소재지 |
| MIL-STD-461F: 2007 |
DEPARTMENT OF DEFENSE INTERFACE STANDARD REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
5.4 CE101, conducted emissions, power leads, 30 Hz to 10 kHz.
5.5 CE102, conducted emissions, power leads, 10 kHz to 10 MHz.
5.7 CS101, conducted susceptibility, power leads, 30 Hz to 150 kHz.
5.11 CS106, conducted susceptibility, transients, power leads.
5.13 CS114, conducted susceptibility, bulk cable injection, 10 kHz to 200 MHz.
5.14 CS115, Conducted susceptibility, bulk cable injection, impulse excitation.
5.15 CS116, conducted susceptibility, damped sinusoidal transients, cables and power leads, 10 kHz to 100 MHz.
5.16 RE101, Radiated emissions, magnetic field, 30 Hz to 100 kHz.
5.17 RE102, radiated emissions, electric field, 10 kHz to 18 GHz.
5.19 RS101, radiated susceptibility, magnetic field, 30 Hz to 100 kHz.
5.20 RS103, radiated susceptibility, electric field, 2 MHz to 40 GHz.
(Exception)
5.19.4 RS101 alternative test procedures – AC Helmholtz coil.
5.20.4 RS103 alternative test procedures – reverberation chamber (mode-tuned). |
CE101 : 30 Hz ~ 10 kHz
CE102 : 10 kHz ~ 10 MHz
CS101 : 30 Hz ~ 150 kHz
CS106 : 400 V
CS114 : 10 kHz ~ 200 MHz
CS115 : 5 A
CS116 : 10 kHz ~ 100 MHz
RE101 : 30 Hz ~ 100 kHz
RE102 : 10 kHz ~ 18 GHz
RS101 : 30 Hz ~ 100 kHz
RS103 : 2 MHz ~ 18 GHz, 60 V/m |
소재지 |
| MIL-STD-461G: 2015 |
DEPARTMENT OF DEFENSE INTERFACE STANDARD REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
5.4 CE101, conducted emissions, audio frequency currents, power leads.
5.5 CE102, conducted emissions, radio frequency potential, power leads.
5.7 CS101, conducted susceptibility, power leads.
5.12 CS114, conducted susceptibility, bulk cable injection.
5.13 CS115, conducted susceptibility, bulk cable injection, impulse excitation.
5.14 CS116, conducted susceptibility, damped sinusoidal transients, cables and power leads.
5.16 CS118, personnel borne electrostatic discharge.
5.17 RE101, radiated emissions, magnetic field.
5.18 RE102, radiated emissions, electric field.
5.20 RS101, radiated susceptibility, magnetic field.
5.21 RS103, radiated susceptibility, electric field.
(Exception)
5.20.4 RS101 alternative test procedures – AC Helmholtz coil.
5.21.4 RS103 alternative test procedures – reverberation chamber (mode-tuned). |
CE101 : 30 Hz ~ 10 kHz
CE102 : 10 kHz ~ 10 MHz
CS101 : 30 Hz ~ 150 kHz
CS114 : 10 kHz ~ 200 MHz
CS115 : 5 A
CS116 : 10 kHz ~ 100 MHz
CS118 : ±2 kV ~ ±15 kV
RE101 : 30 Hz ~ 100 kHz
RE102 : 10 kHz ~ 18 GHz
RS101 : 30 Hz ~ 100 kHz
RS103 : 2 MHz ~ 18 GHz, 60 V/m |
소재지 |
| IEC 60601-2-25:2011 |
Medical electrical equipment - Part 2-25 : Particular requirements for the basic safety and essential performance of electrocardiographs
(Applicable scope)
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility - Requirement and tests |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
F/H : ≤ 16 A
ESD : 15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT/B : ±2 kV
Surge : ±2 kV
CS : 10 V, 0.15 MHz ~ 80 MHz
MF : 30 A/m
V-dip: (0 ~ 100)% |
소재지 |
| IEC 80601-2-26:2019 |
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electro encephalographs
(Applicable scope)
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility - Requirement and tests |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
F/H : ≤ 16 A
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT/B : ±2 kV
Surge : ±2 kV
CS : 10 V, 0.15 MHz ~ 80 MHz
MF : 30 A/m
V-dip: (0 ~ 100)% |
소재지 |
| IEC 60601-2-27:2011 |
Medical electrical equipment - Part 2-27 : Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
(Applicable scope)
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility - Requirement and tests |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
F/H : ≤ 16 A
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT/B : ±2 kV
Surge : ±2 kV
CS : 10 V, 0.15 MHz ~ 80 MHz
MF : 30 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
(Applicable scope)
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility - Requirement and tests |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
F/H : ≤ 16 A
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT/B : ±2 kV
Surge : ±2 kV
CS : 10 V, 0.15 MHz ~ 80 MHz
MF : 30 A/m
V-dip: (0 ~ 100)% |
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
(Applicable scope)
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility - Requirement and tests |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
F/H : ≤ 16 A
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT/B : ±2 kV
Surge : ±2 kV
CS : 10 V, 0.15 MHz ~ 80 MHz
MF : 30 A/m
V-dip: (0 ~ 100)% |
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
(Applicable scope)
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic disturbances - Requirements and tests |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
F/H : ≤ 16 A
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT/B : ±2 kV
Surge : ±2 kV
CS : 10 V, 0.15 MHz ~ 80 MHz
MF : 30 A/m
V-dip: (0 ~ 100)% |
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
(Applicable scope)
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic disturbances - Requirements and tests |
CE : 9 kHz ~ 30 MHz
RE : 150 kHz ~ 18 GHz
F/H : ≤ 16 A
ESD : ±15 kV
RS : 80 MHz ~ 6 GHz, 28 V/m
EFT/B : ±2 kV
Surge : ±2 kV
CS : 10 V, 0.15 MHz ~ 80 MHz
MF : 30 A/m
V-dip: (0 ~ 100)% |
소재지 |
| ▶ 환경 및 신뢰성 |
| IEC 60068-2-1:2025 |
Environmental testing - Part 2-1: Tests - Test A: Cold |
Temperature: (-30 ~ 5) ℃ |
소재지 |
| IEC 60068-2-2:2025 |
Environmental testing - Part 2-2: Tests - Test B: Dry heat |
Temperature: (30 ~ 100) ℃ |
소재지 |
| IEC 60068-2-30:2025 |
Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h+12 h cycle) |
Temperature: (25 ~ 55) ℃
Humidity: (25 ~ 95) % R.H. |
소재지 |
| KS C IEC 60068-2-1:2007 |
환경 시험 - 제2-1부: 시험 - 시험 A: 내한성 시험 |
온도: (-30 ~ 5) ℃ |
소재지 |
| KS C IEC 60068-2-2:2007 |
환경 시험 - 제2-2부: 시험 - 시험 B: 내열성 시험 |
온도: (30 ~ 100) ℃ |
소재지 |
| KS C IEC 60068-2-30:2005 |
환경 시험 ㅡ 제 2-30부: 시험 ㅡ 시험 Db와 지침: 주기적 내습 사이클(12 h+12 h 주기) |
온도: (25 ~ 55) ℃
습도: (45 ~ 95) % R.H. |
소재지 |
