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IEC/TR 60513 Ed. 2.0 b:1994
Fundamental aspects of safety standards for medical electrical equipment
This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment. It 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.
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International Electrotechnical Commission [iec]