Norm

NEN-EN-IEC 62353:2014 en

Medische elektrische toestellen - Periodiek testen en testen na reparatie van medische elektrische toestellen

253,59

Over deze norm

Status Definitief
Aantal pagina's 129
Commissie Medische elektrische toestellen
Gepubliceerd op 01-11-2014
Taal Engels
NEN-EN-IEC 62353 applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1: 2005 (third edition) and its amendments, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME EQUIPMENT or ME SYSTEM is designed. This standard contains: - "general requirements", which contain clauses of general concern, and - "particular requirements", further clauses handling special types of ME EQUIPMENT or ME SYSTEMS and applying in connection with the "General requirements".

Details

ICS-code 11.040
Nederlandse titel Medische elektrische toestellen - Periodiek testen en testen na reparatie van medische elektrische toestellen
Engelse titel Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
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