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:
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those who prepare standards for the design, installation and use of medical electrical equipment;
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health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment;
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manufacturers of medical electrical equipment;
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those who assemble systems which include medical electrical equipment.
This report may also be of assistance to:
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users or operators of medical electrical equipment;
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hospital administrators;
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non-technical personnel involved in the procurement of medical electrical equipment;
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educators and students.
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hospital and clinical engineers responsible for the construction of patient care facilities or for the procurement or maintenance of medical electrical equipment;