• CSA Z17664 : 2006 : R2011

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  02-06-2018

    Language(s):  English

    Published date:  31-12-2015

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Information to be provided by the medical device manufacturer
    4 Presentation of the information
    5 Validation of the reprocessing information provided
    6 Risk analysis
    Annex A (informative) - Commonly utilized reprocessing methods
    Annex B (informative) - An example of reprocessing instructions
            for reusable medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor.

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

    Document Type Standard
    Product Note Reconfirmed EN
    Publisher Canadian Standards Association
    Status Withdrawn
    Superseded By
    Supersedes

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

    EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    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
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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