EN 60601 or IEC 60601 are European harmonized standards that comply with the Medical Device Directive. IEC 60601 is applicable to the basic safety and basic performance of medical electrical equipment and medical electrical systems Although this standard is widely considered comprehensive, it is important to note that in addition to IEC 60601, there are many other standards that address the unique functions and characteristics of medical devices Zhongjian Huatongwei Company is a compliance testing laboratory that conducts EN 60601-1-2 testing in accordance with the European Union Medical Device Directive (93/42/EEC) and/or FDA 510k requirements

IEC 60601-1-2  Summary of EMC/EMI Testing

The testing completed according to IEC 60601 includes the following content:

1. Electrostatic Discharge

2. Radiation Immunity

3. Fast Transients

4. Surge

5. Conducted Immunity

6. Power frequency magnetic field (voltage dips, interruptions, and changes)

There are several clauses in IEC 60601 that require more attention. One of the provisions states that "the basic performance of equipment and systems should be determined through risk analysis. If risk analysis is not conducted, all functions of the equipment or system should be considered as the basic performance for immunity testing." Basic performance is defined in the standard as "the performance characteristics necessary to maintain residual risks within an acceptable range. The basic performance should be determined through risk analysis If the risk analysis is not completed, all functions of the medical device should be considered essential It should be noted that IEC 60601 places the responsibility for determining pass or fail on the equipment manufacturer, rather than the EMC testing laboratory. Ultimately, medical device manufacturers determine which functions are crucial for performance Requirements: Description: IEC 60417: Graphical symbols for use on equipment IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and basic performance IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and basic performance - Supplementary standards: General requirements, testing, and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 61000-3-2, Electromagnetic Compatibility (EMC) - Part 3-2 Limitations - Limits for harmonic current emissions (equipment input current? 16 A per phase) IEC 61000-3-3, Electromagnetic Compatibility (EMC) - Part 3-3: Limitations - Voltage fluctuations and flicker limits in low-voltage power supply systems for rated current equipment&Nbsp; 16 IEC 61000-4-2, Electromagnetic Compatibility (EMC) - Part 4-2: Testing and Measurement Techniques - Electrostatic Discharge Immunity Testing IEC 61000-4-3, Electromagnetic Compatibility (EMC) - Part 4-3: Testing and Measurement Techniques - Radiated, RF, Electromagnetic Field Immunity Testing IEC 61000-4-4, Electromagnetic Compatibility (EMC) - Part 4-4: Testing and Measurement Techniques - Electrical Fast Transient/Burst Immunity Testing IEC 61000-4-5, Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity testing IEC 61000-4-6: 2003, Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances caused by radio frequency fields IEC 61000-4-8, Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity testing IEC 61000-4-11, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions, and voltage changes immunity testing CISPR 11: Industrial Scientific and Medical (ISM) Radio Frequency Equipment - Electromagnetic Interference Characteristics - Limits and Measurement Methods CISPR 14-1: Electromagnetic Compatibility - Household Appliances Requirements for electric tools and similar equipment - Part 1: Emission CISPR 15: Limits and measurement methods for radio interference characteristics of electrical lighting and similar equipment CISPR 16-1-2: Specification for radio interference and immunity measurement equipment and methods - Part 1-2: Radio interference and immunity measurement equipment - Auxiliary equipment - Conducted interference CISPR 22, Information technology equipment - Radio interference characteristics - Limits and measurement methods