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ANSI/AAMI ES60601-1:2005 and A1:2012 and A2:2021 REDLINE
REDLINE VERSION - Medical electrical equipment - Part 1 - General requirements for basic safety and essential performance - Consolidated Text
This standard includes 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. The second amendment addresses changes to terminology and references since the main document was finalized in 2005 and first amended in 2012.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]