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  • ANSI/AAMI/ISO 17664:2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-01-2024

    Language(s):  English

    Published date:  18-08-2017

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of
     ISO 17664:2017
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Validation of the processes identified in
      the information provided by the medical
      device manufacturer
    5 Risk analysis
    6 Information to be provided by the
      medical device manufacturer
    7 Presentation of the information
    Annex A (informative) - Commonly utilized
            processing methods
    Annex B (informative) - Example of processing
            instructions for reusable medical devices
    Annex C (informative) - Classification of medical
            devices
    Annex D (informative) - Additional guidance on
            information to be provided by the medical
            device manufacturer
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes AAMI ST81. (11/2017)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    AAMI TIR16 : 2017 MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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