ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 & A2:2021 Redline

This standard contains the 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. Annex 3