Electromagnetic Compatibility (EMC) of Medical Devices in conjunction with IEC TS 60601-4-2:2024

05. July 2024

Medical electrical equipment is used in medical practice because it provides necessary functions associated with its intended use. It is expected the medical electrical devices or medical electrical systems must be safe and function as intended.

In general, IEC 60601-1-2 specifies the immunity test levels for basic safety and essential performance based on the reasonably foreseeable maximum levels of electromagnetic disturbance. As there are no criteria for performance in general in IEC 60601-1-2, the Technical Specification IEC TS 60601-4-2:2024 has been developed. The purpose of this Technical Specification is to address the performance of medical electrical equipment and medical electrical systems. This Technical Specification provides guidance on the assessment of immunity with regard to the intended use. In this Technical Specification, the immunity test levels for performance are based on typical values for electromagnetic disturbances and are lower than in IEC 60601-1-2. The FDA recommends compliance with this Technical Specification.

We hereby announce that we can test according to the Technical Specifications IEC TS 60601-4-2. We have successfully passed the requirements for accreditation by the Slovenian accreditation.

Here are the differences between IEC 60601-1-2 and IEC TS 60601-4-2:

	IEC TS 60601-4-2	IEC 60601-1-2
Emission	Not required!	Conducted emissions Radiated emissions Harmonics currents Voltage fluctuations
Immunity	Yes	Yes
Immunity test levels	ESD: Contact: 4 kV; Air: 8 kV Radiated RF fields: 3 V/m Proximity electromagnetic fields: 6-9 V/m EFT/Burst: 1 kV Conducted RF fields: 3 V_RMS Power frequency magnetic fields: 3 A/m DIPS: 0 % @ 0.5 cycle; 70 % @ 25 cycles;0 % @ 250 cycles Proximity magnetic fields: Not applicable	ESD: Contact: 8 kV; Air: 15 kV Radiated RF fields: 3 V/m or 10 V/m Proximity electromagnetic fields: 9-28 V/m EFT/Burst: 2 kV Conducted RF fields: 3 V_RMS+ 6 V_RMS (ISM & Amateur) Power frequency magnetic fields: 30 A/m DIPS: 0 % @ 0.5 cycle; 0 % @ 1 cycle; 70 % @ 25 cycles; 0 % @ 250 cycles Proximity magnetic fields: 30 kHz @ 8 A/m; 134.2 kHz @ 65 A/m; 13.56 MHz @ 7.5 A/m
Observation during Immunity testing	Performance	Basic Safety & Essential Performance
Operating modes used for testing	That are most likely to result in unacceptable degradation of performance of the medical device.	That are most likely to result in an unacceptable RISK to the patient or operator.
Acceptance criteria	Performance criteria A, B and C	PASS/FAIL criteria for Basic Safety & Essential Performance
Documentation	Instruction for Use only	Instruction for Use & Risk Management File

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