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AAMI

Association for the Advancement of Medical Instrumentation 1988 – 2024

Showing 161–176 of 342 results

  • AAMI 10993 7 2008 RA 2012

    AAMI 10993 7 2008 RA 2012

    ANSI/AAMI/ISO 10993-7:2008/(R)2012 – Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals Published By…

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  • AAMI 11138 7 2019

    AAMI 11138 7 2019

    ANSI/AAMI/ISO 11138-7:2019 – Sterilization of health care products-Biological indicators-Part 7: Guidance for the selection, use…

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  • AAMI 11138 1 2017

    AAMI 11138 1 2017

    ANSI/AAMI/ISO 11138-1:2017 – Sterilization of health care products-Biological indicators-Part 1: General requirements Published By Publication…

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  • AAMI TIR67 2018

    AAMI TIR67 2018

    AAMI TIR67:2018 – Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals…

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  • AAMI TIR34 2014 RA 2017

    AAMI TIR34 2014 RA 2017

    AAMI TIR34: 2014/(R)2017 – Water for the reprocessing of medical devices Published By Publication Date…

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  • AAMI ST65 2008 RA 2018

    AAMI ST65 2008 RA 2018

    ANSI/AAMI ST65:2008/(R)2018 – Processing of reusable surgical textiles for use in health care facilities Published…

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  • AAMI ST91 2015

    AAMI ST91 2015

    ANSI/AAMI ST91:2015 – Flexible and semi-rigid endoscope processing in healthcare facilities Published By Publication Date…

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  • AAMI TIR38 2019

    AAMI TIR38 2019

    AAMI TIR38:2019 – Medical device safety assurance case guidance Published By Publication Date Number of…

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  • AAMI 13485 2016 RA 2019

    AAMI 13485 2016 RA 2019

    ANSI/AAMI/ISO 13485:2016/(R)2019 – Medical devices-Quality management systems-Requirements for regulatory purposes Published By Publication Date Number…

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  • AAMI TIR97 2019

    AAMI TIR97 2019

    AAMI TIR97:2019 – Principles for medical device security-Postmarket risk management for device manufacturers Published By…

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  • AAMI TIR45 2012 RA 2018

    AAMI TIR45 2012 RA 2018

    AAMI TIR45:2012/(R)2018 – Guidance on the use of AGILE practices in the development of medical…

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  • AAMI TIR69 2017

    AAMI TIR69 2017

    AAMI TIR69:2017 – Risk management of radio-frequency wireless coexistence for medical devices and systems Published…

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  • AAMI SW91 2018

    AAMI SW91 2018

    ANSI/AAMI SW91:2018 – Classification of defects in health software Published By Publication Date Number of…

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  • AAMI TIR80002 1 2009

    AAMI TIR80002 1 2009

    AAMI/IEC TIR80002-1:2009 – Medical device software – Part 1: Guidance on the application of ISO…

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  • AAMI TIR80001 2 8 2016

    AAMI TIR80001 2 8 2016

    AAMI/IEC TIR80001-2-8:2016 – Application of risk management for IT networks incorporating medical devices. Part 2-8:…

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  • AAMI TIR80001 2 2 2012

    AAMI TIR80001 2 2 2012

    AAMI/IEC TIR80001-2-2:2012 – Application of risk management for IT-networks incorporating medical devices-Part 2-2: Guidance for…

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