Fundamental Aspects of Safety Standards for Medical Electrical Equipment
|Publication Date:||1 January 1994|
|ICS Code (Medical equipment in general):||11.040.01|
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.