PD 6573:1994

This standard PD 6573:1994 Fundamental aspects of safety standards for medical electrical equipment is classified in these ICS categories:

• 11.040.01 Medical equipment in general

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 51¹ 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;