IEC 60601-1-2 Standard (edition 4.0)
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
TS EN 60601-1-2 standard is one of the Electromagnetic Compatibility (EMC) product family standards. Electrical medical product manufacturers design their products according to the TS EN 60601-1-2 standard and have them tested (EMC Test).
The TS EN 60601-1-2 standard covers general EMC specifications for basic safety and required performance for electrical medical devices and systems.
The purpose of the TS EN 60601-1-2 standard is to specify the general characteristics and tests (EMC Test) for the electromagnetic compatibility (EMC) of electrical medical devices and systems.
Electromagnetic Compatibility (EMC) Tests:
Electromagnetic Compatibility Tests (EMC Test) are aimed to operate any electrical and electronic device or system without being affected by and affecting other devices or systems in the environment. EMC Tests are examined in 2 general categories as immunity and emission.
Emission Tests specified in IEC 60601-1-2;
- Radiated Emission Test - CISPR 11 / EN 55011
- Conducted Emission Test - CISPR 11 / EN 55011
- Harmonics Test - EN 61000-3-2
- Flicker Test - EN 61000-3-3
Immunity Tests specified in IEC 60601-1-2;
- Electrostatic Discharge (ESD) Test - EN 61000-4-2
- Radiated Immunity Test - EN 61000-4-3
- Electrical Fast Transients / Burst Test - EN 61000-4-4
- Surge Testi - EN 61000-4-5
- Conducted Immunity Test - EN 61000-4-6
- Magnetic Fields - EN 61000-4-8
- Voltage Dips and Interruptions Test - EN 61000-4-11
Immunity Test Specifications
Enclosure Ports;
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EMC Test |
Immunity Test Level
|
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ESD 61000-4-2 |
Contact: ±8 kV Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV |
|
Radiated Immunity 61000-4-3 |
3 V/m* or 10 V/m* 80 MHz – 2,7 GHz %80 AM – 1 kHz |
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Magnetic Fields 61000-4-8 |
30 A/m 50-60 Hz |
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* It varies according to the structure and usage environment of the device. |
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AC Power Port;
|
EMC Test |
Immunity Test Level
|
|
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Burst / EFT 61000-4-4 |
±2 kV 100 kHz |
|
|
Surge 61000-4-5 |
±0,5 kV, ±1 kV Line to Line ±0,5 kV, ±1 kV, ±2 kV Line to Ground |
|
|
Conducted Immunity 61000-4-6 |
3 V/m 0,15 MHz – 80 MHz %80 AM – 1 kHz |
|
|
Voltage dips - Interruptions 61000-4-11 |
%0 UT=0,5 cycle* %0 UT=1 cycle %70 UT=25/30 cycle |
%0 UT= 250/300 cycle |
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* It varies according to the structure and usage environment of the device. |
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DC Power Port;
|
EMC Test |
Immunity Test Level
|
|
Burst / EFT 61000-4-4 |
±2 kV 100 kHz |
|
Surge 61000-4-5 |
±0,5 kV, ±1 kV Line to Line ±0,5 kV, ±1 kV, ±2 kV Line to Ground |
|
Conducted Immunity 61000-4-6 |
3 V/m 0,15 MHz – 80 MHz %80 AM – 1 kHz |
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* It varies according to the structure and usage environment of the device. |
|
Performance Criteria
Basic safety and required performance must be ensured for EMC Tests applied to electrical medical devices and systems. During or after the test; component failures, changes in programmable parameters, factory reset, change of operating mode, false alarms, noise or disturbance that may affect diagnosis, treatment and monitoring, etc. too many performance drops are not allowed.