Product Testing and Certification

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. Medical electrical devices or medical electrical systems are expected to be safe and to function as intended.

In general, IEC 60601-1-2 specifies immunity test levels for basic safety and essential performance based on the reasonably foreseeable maximum levels of electromagnetic disturbances. As there are no criteria for performance in general in IEC 60601-1-2, 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. It 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 levels of electromagnetic disturbances. Compliance with this technical specification is recommended by the FDA.

We are proud to announce that we can test according to IEC TS 60601-4-2 as we have successfully passed the accreditation assessment by the Slovenian Accreditation. We are expecting to receive the updated scope soon.

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 Yes
Immunity Yes Yes
Observation during Immunity testing Performance Basic Safety & Essential Performance
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 VRMS
  • 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 VRMS + 6 VRMS (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: Applicable
Operating modes used for testing That are most likely to result in unacceptable degradation of performance. That are most likely to result in an unacceptable RISK.
Acceptance criteria Performance criteria A, B, and C PASS/FAIL for basic safety & essential performance
Documentation Instructions for use only Instructions for use & risk management file
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