Current AAMI Standards

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  • Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

    Standard [CURRENT] 2016

    AAMI/IEC 60601-2-19+A1:2016

    Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

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  • Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

    Standard [CURRENT] 2015

    AAMI/ISO 80369-20:2015

    Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

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  • General testing procedures for medical electrical equipment

    Technical rule [CURRENT] 2015

    AAMI/IEC TIR 62354:2015

    General testing procedures for medical electrical equipment

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  • Graphic symbols for electrical equipment in medical practice

    Technical rule [CURRENT] 2015

    AAMI/IEC TIR 60878:2015

    Graphic symbols for electrical equipment in medical practice

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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

    Standard [CURRENT] 2015

    AAMI HA 60601-1-11:2015

    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

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    This document has been modified by: AAMI HA 60601-1-11/A1:2021

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  • Sustainability of medical devices - Elements of a responsible product life cycle

    Technical rule [CURRENT] 2015

    AAMI TIR 65:2015

    Sustainability of medical devices - Elements of a responsible product life cycle

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  • Guidance for the use of medical equipment maintenance strategies and procedures

    Standard [CURRENT] 2015

    AAMI EQ 89:2015

    Guidance for the use of medical equipment maintenance strategies and procedures

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  • Post-market surveillance of use error management

    Technical rule [CURRENT] 2014

    AAMI TIR 50:2014

    Post-market surveillance of use error management

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  • Human factors engineering - Guidance for contextual inquiry

    Technical rule [CURRENT] 2014

    AAMI TIR 51:2014

    Human factors engineering - Guidance for contextual inquiry

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  • Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements

    Technical rule [CURRENT] 2014

    AAMI/ISO TIR 80001-2-6:2014

    Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements

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