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About This Item

 

Full Description

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. These medical electrical equipment and medical electrical systems will often be supervised by non-healthcare personnel with different levels of training.
 

Document History

  1. AAMI HA60601-1-11:2015 & A1:2021


    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) CONSOLIDATED EDITION

    • Most Recent
  2. AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

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    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)

    • Historical Version
  3. AAMI/IEC HA60601-1-11:2011(IEC 60601-1-11:2010, MOD)


    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 60601-1-11:2010, MOD)

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. 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)