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ANSI/AAMI ES60601-1:2005 (R2012) (IEC 60601-1:2005 MOD)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (contains C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) )

Baseline of requirements for the basic safety and essential performance of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. Also contains certain requirements for reliable operation to ensure safety. This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

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Association for the Advancement of Medical Instrumentation [aami]

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