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    • AAMI
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    ANSI/AAMI/ISO 11607-1:2019

    Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems

    Association for the Advancement of Medical Instrumentation

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    ANSI/AAMI/ISO 11607-2 : 2019

    Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

    Association for the Advancement of Medical Instrumentation

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    AAMI TIR75:2019

    Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples

    Association for the Advancement of Medical Instrumentation

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    ANSI/AAMI/ ISO 14971:2019

    Medical devices—Application of risk management to medical devices

    Association for the Advancement of Medical Instrumentation

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    ANSI/AAMI/ ISO 81060-2:2019

    Non-invasive sphygmomanometers— Part 2: Clinical investigation of intermittent automated measurement type

    Association for the Advancement of Medical Instrumentation

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    ANSI/AAMI/ ISO 11137-2: 2013(R2019)

    STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE

    Association for the Advancement of Medical Instrumentation

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    ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019

    Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

    Association for the Advancement of Medical Instrumentation

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    ANSI/AAMI EQ93:2019

    Medical equipment management—Vocabulary used in medical equipment programs

    Association for the Advancement of Medical Instrumentation

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    ANSI/AAMI/UL 2800-1 : 2019

    Standard for Safety for Medical Device Interoperability.

    Association for the Advancement of Medical Instrumentation

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    AAMI TIR38:2019

    Medical device safety assurance case guidance

    Association for the Advancement of Medical Instrumentation

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