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AAMI HA60601-1-11:2015/A1:2021
M00001571
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AAMI HA60601-1-11:2015/A1:2021 Amendment 1, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD)
Amendment by Association for the Advancement of Medical Instrumentation, 03/20/2022
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This amendment to ANSI/AAMI HA60601-1-11:2015 addresses changes to terminology and references since the main document was finalized. The main document and this amendment provide requirements for the safety and essential performance requirements for all medical electrical equipment and medical electrical systems used in the home healthcare environment.