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    AS ISO 10993.17-2004

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  30-06-2017

    Language(s):  English

    Published date:  01-01-2004

    Publisher:  Standards Australia

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    Abstract - (Show below) - (Hide below)

    Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. Not applicable to devices that have no patient contact, e.g. in vitro diagnostic devices. The Standard is identical to, and has been reproduced from, ISO 10993-17:2002.

    Scope - (Show below) - (Hide below)

    This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.

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

    Committee HE-012
    Document Type Standard
    Publisher Standards Australia
    Status Withdrawn
    Supersedes

    History - (Show below) - (Hide below)

    First published as AS ISO 10993.17-2004.

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