The British Standards Institution (BSI) has published the latest guidance for medical electrical equipment: BS EN 60601-1:2006 Medical electrical equipment
General requirements for basic safety and essential performance is for manufacturers, regulation bodies, independent certification bodies and professional users and beneficiaries of medical electrical equipment.
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; and the professional users, patients and disabled persons who depend on the equipment.
