Norm

IEC/TR 62348:2012 en

Beoordeling van de impact van de meest belangrijke veranderingen in Amendment 1 bij IEC 60601-1:2005 en betrekking op de clausules van IEC 60601-1:2005 bij de vorige editie

249,27

Over deze norm

Status Definitief
Aantal pagina's 101
Commissie Medische elektrische toestellen
Gepubliceerd op 01-12-2012
Taal Engels
This technical report provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012. This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by: - those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended; - manufacturers of medical electrical equipment or medical electrical systems; - health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems.

Details

ICS-code 11.040
Nederlandse titel Beoordeling van de impact van de meest belangrijke veranderingen in Amendment 1 bij IEC 60601-1:2005 en betrekking op de clausules van IEC 60601-1:2005 bij de vorige editie
Engelse titel Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
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