Identifies fundamental considerations for developing standards to ensure the safety of medical electrical equipment. Coverage includes: factors affecting safety; measures to achieve safety; acceptable risk levels; standards and the law; maintenance of standards. Also gives detailed tables, diagrams and annexes.

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/IECGuide51¹and 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;