Medical electrical equipment

BSI participates in the area of medical electrical equipment as the UK representative on the international committee IEC/TC 62 and its sub-committees. Current work involves:

  • implementing the third edition of BS EN 60601-1 which integrates the principles of risk management
  • providing the UK input in the process of aligning of the already published particular and collateral standards to the third edition of BS EN 60601-1 as part of a maintenance scheme
  • providing the UK input in the development of standards for new technologies in health care safety and performance
  • providing the UK input into the maintenance of guidance documents to assist users in developing procedures for maintaining compliance with technical specification during the useful life of medical electrical equipment.

If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:

BS EN 60601-1:2006+A12:2014
Medical electrical equipment. General requirements for basic safety and essential performance

The IEC 60601 series does not apply to:

  • in vitro diagnostic equipment that does not fall within the definition of ME Equipment, which is covered by the IEC 61010 series (61)
  • implatable parts of active implantable medical device s covered by the ISO 14708 series (69)
  • medical gas pipeline sustems covered by ISO 7396-1 (68)

The object of this standard is to specify general requirements and to serve as the basis for particular standards.

BS EN 60601-1-2:2015
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests

BS EN IEC 60601-2-16:2019
Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

BS EN 60601-1-11:2015
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

BS EN 60601-2-25:2015
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs

BS EN 60601-2-25:2015
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs

BS EN IEC 80601-2-26:2020
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electroencephalographs

BS EN 55011:2016+A11:2020
Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement


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