Medizintechnik

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  • Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

    Standard [CURRENT] 2025-03

    DIN 58953-6:2025-03

    Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

    Corrected document: Customers who purchased the previous document DIN 58953-6:2023-11 received free of charge

    from 80.20 EUR VAT included

    from 74.95 EUR VAT excluded

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  • Sterilization - Sterile supply - Part 9: Use of re-usable sterilization containers; Text in German and English

    Standard [CURRENT] 2024-10

    DIN 58953-9:2024-10

    Sterilization - Sterile supply - Part 9: Use of re-usable sterilization containers; Text in German and English

    from 65.70 EUR VAT included

    from 61.40 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2025

    Standard [NEW] 2025-09

    DIN EN 868-2:2025-09

    Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2025

    from 102.10 EUR VAT included

    from 95.42 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3:2025

    Standard [NEW] 2025-09

    DIN EN 868-3:2025-09

    Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3:2025

    from 94.60 EUR VAT included

    from 88.41 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2025

    Standard [NEW] 2025-09

    DIN EN 868-4:2025-09

    Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2025

    from 87.90 EUR VAT included

    from 82.15 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2025

    Standard [NEW] 2025-09

    DIN EN 868-6:2025-09

    Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2025

    from 94.60 EUR VAT included

    from 88.41 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2025

    Standard [NEW] 2025-09

    DIN EN 868-7:2025-09

    Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2025

    from 109.50 EUR VAT included

    from 102.34 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023

    Standard [CURRENT] 2024-02

    DIN EN ISO 11607-1:2024-02

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023

    from 192.20 EUR VAT included

    from 179.63 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023); German version EN ISO 11607-2:2020 + A1:2023

    Standard [CURRENT] 2024-02

    DIN EN ISO 11607-2:2024-02

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023); German version EN ISO 11607-2:2020 + A1:2023

    This document provides the framework for activities and requirements for the development and validation of the processes used in the manufacture and assembly of the packaging system. This part of ...

    from 121.20 EUR VAT included

    from 113.27 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025); German and English version prEN ISO 11607-3:2025

    Draft standard 2025-09

    DIN EN ISO 11607-3:2025-09 - Draft

    Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025); German and English version prEN ISO 11607-3:2025

    from 115.70 EUR VAT included

    from 108.13 EUR VAT excluded

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