Most recent
ANSI/AAMI HA60601-1-11:2015 and A1:2021 REDLINE
REDLINE VERSION - 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 - Consolidated Text (IEC 60601-1-11:2015, MOD)
This standard applies to the safety and essential performance of medical electrical equipment and medical electrical systems, which are intended by the manufacturer for use in home care applications usually without continual professional supervision and temporarily in the clinical environment. These medical electrical equipment and medical electrical systems will frequently be used in locations where driving power and safety means of the electrical installation is not reliable. The amendment addresses changes to terminology and references since the main document was finalized.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
