Revised standards 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 covers 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 various sectors, including manufacturers who can supply 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.

BS EN 60601-1:2006 supersedes BS EN 60601-1:1990 and BS 5724-1:1989.

Visit: www.bsi-global.com/BSEN60601 for more information.

Also available is BS EN 60601-2-12:2006 Medical electrical equipment. Particular requirements for the safety of lung ventilators, which sets the minimum requirements that should be met by every critical care ventilator designed after the publication of this standard.

The standard specifies the safety requirements for ventilators intended for use in critical care settings.

BS EN 60601-2-12 should be read in conjunction with BS EN 60601-1:2006. BS EN 60601-2-12:2006 supersedes BS EN 794-1:1997 which has been withdrawn.

BS EN 60601-2-27:2006 Medical electrical equipment. Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment concerns the safety of electrocardiographic monitoring equipment.

It introduces general guidance and rationale for the essential performance of equipment such as defibrillator protection, performance requirements and alarming. BS EN 60601-2-27:2006 supersedes BS EN 6061-2-27:1995 which has been withdrawn.

Finally, Medical Devices: ISO 13485 and ISO 9001 by Dr Dennis Green takes the reader through the clauses of both standards, providing essential information on ISO 13485, ISO 9001 and quality management system auditing.

For further information contact the BSI on 020 8996 9001 or visit: www.bsonline.bsi-global.com