scope:

This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment.

NOTE - This report follows closely recommendations of ISO/IEC Guide 51* and expands on matters which are unique to, or critical in, the application of medical electrical equipment.

This report is primarily intended to be used by:

- those who prepare standards for the design, installation and use of medical electrical equipment;

- health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment;

- manufacturers of medical electrical equipment;

- those who assemble systems which include medical electrical equipment.

This report may also be of assistance to:

- users or operators of medical electrical equipment;

- hospital administrators;

- non-technical personnel involved in the procurement of medical electrical equipment;

- educators and students.

- hospital and clinical engineers responsible for the construction of patient care facilities or for the procurement or maintenance of medical electrical equipment;

* ISO/IEC Guide 51: 1990, Guidelines for the inclusion of safety aspects in standards.