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    • Sterilized packaging
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    SR CEN ISO/TS 16775:2014

    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)

    National Standards Authority of Ireland

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    I.S. EN ISO 11607-1:2020&LC:2020

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

    National Standards Authority of Ireland

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    I.S. EN 868-5:2018

    Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

    National Standards Authority of Ireland

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    PN-EN ISO 11607-2:2020-06

    Packaging for final sterilized medical devices - Part 2: Validation requirements for molding, sealing and assembly processes

    Polish Committee for Standardization

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    PN-EN ISO 11607-1:2020-06

    Packaging for final sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

    Polish Committee for Standardization

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    DIN EN ISO 11607-1 E : 2020

    Packaging for terminally sterilized medical devices- Part1: Requirements for materials, sterile barrier systems and packaging systems (ISO11607-1:2019); German version ENISO11607-1:2020

    German Institute for Standardisation (Deutsches Institut für Normung)

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    DIN EN ISO 11607-2 E : 2020

    Packaging for terminally sterilized medical devices- Part2: Validation requirements for forming, sealing and assembly processes (ISO11607-2:2019); German version ENISO11607-2:2020

    German Institute for Standardisation (Deutsches Institut für Normung)

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    ÖNORM EN ISO 11607-2:2020 04 15

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

    Osterreichisches Normungsinstitut/Austrian Standards

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    UNI EN ISO 11607-2:2020

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

    Ente Nazionale Italiano di Unificazione (UNI)

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    NEN-EN-ISO 11607-2:2020

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

    Netherlands Standards

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