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  • BS EN ISO 11607-2:2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Packaging for terminally sterilized medical devices Validation requirements for forming, sealing and assembly processes

    Available format(s):  Hardcopy, PDF

    Superseded date:  20-01-2020

    Language(s):  English

    Published date:  15-05-2018

    Publisher:  British Standards Institution

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    Abstract - (Show below) - (Hide below)

    This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
    This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

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    Committee CH/198
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes
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