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:

• Active Implantable Medical Devices (AIMDD) Council Directive 90/385/EEC (1990)
• Medical Devices Directive (MDD) Council Directive 93/42/EEC (1992)
• In Vitro Diagnostic Directive (IVDD) Council Directive 98/79/EC (1998).
   

BS EN 60601-1:2006
Medical electrical equipment, General requirements for basic safety and essential performance

Newly revised and now in its third edition, BS EN 60601-1:2006 applies to medical electrical equipment intended to be used in the diagnosis, treatment, or monitoring of a patient or for compensation or alleviation of disease, injury or disability. This international standard focuses on the basic safety and essential performance of medical electrical equipment and medical electrical systems.

BS EN 60601-1:2006 encapsulates a large body of expertise on safety and performance from around the world, for the benefit of:

• manufacturers - who can satisfy many markets around the world with a single design
• regulatory bodies and independent certification bodies who assess safety and performance
• the professional users, patients and disabled persons who depend on the equipment.

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 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 60601-2-2:2009+A11:2011 
Medical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

BS EN 60601-2-19:2009+A1:2011 
Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant incubators

BS EN 60601-2-31:2008+A1:2011 
Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

BS EN 55011:2009+A1:2010
Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement

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