Norm

IEC 60601-1:2005+A1:2012 en

Medische elektrische toestellen - Deel 1: Algemene eisen voor basisveiligheid en essentiële prestaties

Volledig inclusief:

706,27

Over deze norm

Status Definitief
Aantal pagina's 415
Commissie Medische elektrische toestellen
Gepubliceerd op 01-08-2012
Taal Engels
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. The IEC 60601 series does not apply to: - in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; - implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or - medical gas pipeline systems covered by ISO 7396-1 [68].

Details

ICS-code 11.040.01
Nederlandse titel Medische elektrische toestellen - Deel 1: Algemene eisen voor basisveiligheid en essentiële prestaties
Engelse titel Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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