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  1. MOST RECENT

    Std

    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

    standard by Association for the Advancement of Medical Instrumentation, 08/22/2022.

    Languages: English

    Historical Editions: AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD), AAMI/IEC HA60601-1-11:2011(IEC 60601-1-11:2010, MOD)

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  2. MOST RECENT

    2256670

    AAMI 2800-1-2:2022▹

    Standard for Interoperable Item Development Life Cycle (ANSI/AAMI/UL 2800-1-2:2022)

    standard by Association for the Advancement of Medical Instrumentation, 06/10/2022.

    Languages: English

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  3. MOST RECENT

    2256667

    AAMI 2800-1:2022▹

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)

    standard by Association for the Advancement of Medical Instrumentation, 06/10/2022.

    Languages: English

    Historical Editions: AAMI 2800-1:2019

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  4. MOST RECENT

    2256669

    AAMI 2800-1-1:2022▹

    Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)

    standard by Association for the Advancement of Medical Instrumentation, 06/10/2022.

    Languages: English

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  5. MOST RECENT

    2256672

    AAMI 2800-1-3:2022▹

    Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)

    standard by Association for the Advancement of Medical Instrumentation, 06/10/2022.

    Languages: English

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  6. MOST RECENT

    2254539

    AAMI TIR100: 2021▹

    End-to-end microbiological quality and sterility assurance

    standard by Association for the Advancement of Medical Instrumentation, 05/10/2022.

    Languages: English

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  7. MOST RECENT

    2253259

    AAMI 2700-2-1: 2022▹

    Medical devices and medical systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging

    standard by Association for the Advancement of Medical Instrumentation, 04/22/2022.

    Languages: English

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  8. MOST RECENT

    2252548

    AAMI TIR104:2022▹

    Guidance on transferring health care products between radiation sterilization sources

    standard by Association for the Advancement of Medical Instrumentation, 04/19/2022.

    Languages: English

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  9. HISTORICAL

    2251402

    AAMI CR34971:2022▹

    This document has been replaced. View the most recent version.

    Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

    standard by Association for the Advancement of Medical Instrumentation, 04/01/2022.

    Languages: English

    Historical Editions: AAMI TIR34971:2023

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  10. MOST RECENT

    2250071

    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.

    Languages: English

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