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EVS-EN 60601-1:2006

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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

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.

See standard on harmoneeritud standard Direktiivi 93/42/EÜ (meditsiiniseadmed) mõistes, arvestades järgmist märkust:
"Märkuste 1 ja 3 addendum kuupäevade kohta, mil vastavuseeldus kaotab standardi EN 60601-1:2006  kohaldamise raames kehtivuse. Vastavuseeldus kaotab standardi EN 60601-1:2006  kohaldamise raames kehtivuse 31. detsembril 2017. Standardi EN 60601-1:2006 ZZ lisaga aga ei tagata eeldatavat vastavust direktiivi 93/42/EMÜ olulistele nõuetele enam alates 31. detsembrist 2015. Alates 1. jaanuarist 2016 tagavad eeldatava vastavuse direktiivi 93/42/EMÜ olulistele nõuetele üksnes standardi EN 60601-1:2006  sätted ja alapunktid, mis vastavad standardi EN 60601-1:2006/A1:2013  ZZ lisas osutatud sätetele ja alapunktidele; seda standardi EN 60601-1:2006/A1:2013 ZZ lisas nimetatud ulatuses."

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