General Aspects of Medical Devices

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  1. MOST RECENT

    AAMI/ISO 10993-15:2019▹

    Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 10/05/2020.

    Languages: English

    Historical Editions: AAMI/ISO 10993-15:2000/(R)2011

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  2. HISTORICAL

    AAMI/ISO 14971:2007/(R)2016▹

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

    Medical Devices - Application of Risk Management to Medical Devices

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/23/2007.

    Languages: English

    Historical Editions: AAMI/ISO 14971:2019, AAMI/ISO 14971:2000/A1:2003, AAMI 14971

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  3. MOST RECENT

    AAMI/ISO 14971:2019▹

    Medical devices - Application of risk management to medical devices

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 05/01/2019.

    Languages: English

    Historical Editions: AAMI/ISO 14971:2007/(R)2016, AAMI/ISO 14971:2000/A1:2003, AAMI 14971

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  4. HISTORICAL

    AAMI/ISO 15225:2010▹

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

    Medical devices - Quality management - Medical device nomenclature data structure

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/20/2010.

    Languages: English

    Historical Editions: AAMI/ISO 15225:2016, AAMI/ISO 15225:2000 + Amendment 1, AAMI/ISO 15225:2000 (R2006), AAMI/ISO 15225:2000/(R)2006

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  5. AAMI/ISO 15225:2016▹ [ Withdrawn ]

    Medical devices - Quality management - Medical device nomenclature data structure

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/10/2016.

    Languages:

    Historical Editions: AAMI/ISO 15225:2010, AAMI/ISO 15225:2000 + Amendment 1, AAMI/ISO 15225:2000 (R2006), AAMI/ISO 15225:2000/(R)2006

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  6. MOST RECENT

    AAMI/ISO 16142-1:2016▹

    Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/10/2016.

    Languages: English

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  7. MOST RECENT

    AAMI/ISO 16142-2:2017▹

    Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

    standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/31/2017.

    Languages: English

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  8. MOST RECENT

    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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  9. HISTORICAL

    AAMI 2800-1:2019▹

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

    Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)

    standard by Association for the Advancement of Medical Instrumentation, 02/25/2019.

    Languages: English

    Historical Editions: AAMI 2800-1:2022

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  10. MOST RECENT

    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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