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    • CSA ISO 11607-2:21

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    CSA ISO 11607-2:21

    Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02)

    SKU: 2703996 Published by CSA Group Publication Year 2021

    Product Details

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    CSA Preface


    This is the second edition of CSA ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11607-2 (second edition, 2019-02). It supersedes the previous edition, published in 2016 as CAN/CSA-ISO 11607-2 (adopted ISO 11607-2:2006, including Amendment 1:2014).


    CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Quebec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).


    This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


    Scope


    This document specifies requirements for the 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.


    It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.


    It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

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    CSA ISO 11607-2:21

    Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02)

    Active
    English

    CSA ISO 11607-2:F21

    Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 2 : Exigences de validation pour les procédés de formage, scellage et assemblage (norme ISO 11607-2:2019 adoptée, deuxième édition, 2019-02)

    Active
    French

    CAN/CSA-ISO 11607-2:16

    Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2006, first edition, 2006-04-15, including amendment 1:2014)

    Withdrawn
    English

    CAN/CSA-ISO 11607-2:F16

    Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 2 : Exigences de validation pour les procédés de formage, scellage et assemblage (norme ISO 11607-2:2006 adoptee, première édition, 2006-04-15, y compris l’amendement 1:2014)

    Withdrawn
    French
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