BS EN 60601-1:2006/A12:2014
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Medical electrical equipment. General requirements for basic safety and essential performance
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English
08-18-2018
This International Standard applies to t he BASIC SAFETY a nd ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL E QUIPMENT a nd MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.If a clause o r subclause is s pecifically intended to b e 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 c overed by specific requirements in this standard except in 7.2.13 and 8.4.1.
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