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    • CAN/CSA-ISO 11607-1:16
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    CAN/CSA-ISO 11607-1:16

    Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2006, first edition, 2006-04-15, including amendment 1:2014)

    SKU: 2424759 Published by CSA Group Publication Year 2016 58 pages Withdrawn

    Product Details

    • Preface/Scope

    CSA Preface


    This is the first edition of CAN/CSA-ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11607-1 (first edition, 2006-04-15), including Amendment 1:2014.


    For brevity, this Standard will be referred to as CAN/CSA-ISO 11607-1 throughout.


    This Standard is one of two Standards developed by the Canadian Mirror Committee to ISO/TC 198 that are being adopted by CSA Group under the series Packaging for terminally sterilized medical devices, which consists of the following:


    a) ISO 11607-1, Part 1: Requirements for materials, sterile barrier systems and packaging systems; and


    b) ISO 11607-2, Part 2: Validation requirements for forming, sealing and assembly processes.


    Scope


    This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.


    This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.


    This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.


    This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.

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    GST REG No R119441681
    QST REG No R1006017360

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    Select the subscription format that is right for you. Table with 13 rows and 3 columns, identifies features available and not available for the two different subscription formats - CSA Advantage TM and CSA OnDemand TM
    Features CSA AdvantageTM CSA OnDemandTM
    Offline access CSA AdvantageTM. feature available. Offline access CSA OnDemandTM. feature available. Offline access
    Full-text search CSA AdvantageTM. feature available. Full-text search CSA OnDemandTM. feature available. Full-text search
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    Newest editions added automatically CSA AdvantageTM. feature available. Newest editions added automatically CSA OnDemandTM. feature available. Newest editions added automatically
    Includes all supported languages and archive versions CSA AdvantageTM. feature not available. Includes all supported languages and archive versions CSA OnDemandTM. feature available. Includes all supported languages and archive versions
    My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA AdvantageTM. feature available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA OnDemandTM. feature not available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference
    Toggle between your files and the full standard to maintain context CSA AdvantageTM. feature available. Toggle between your files and the full standard to maintain context CSA OnDemandTM. feature not available. Toggle between your files and the full standard to maintain context
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