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 and English version prEN 868-2:2024

    Draft standard 2024-05

    DIN EN 868-2:2024-05 - Draft

    Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2024

    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 and English version prEN 868-3:2024

    Draft standard 2024-05

    DIN EN 868-3:2024-05 - Draft

    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 and English version prEN 868-3:2024

    from 102.10 EUR VAT included

    from 95.42 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German and English version prEN 868-4:2024

    Draft standard 2024-05

    DIN EN 868-4:2024-05 - Draft

    Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German and English version prEN 868-4:2024

    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 and English version prEN 868-6:2024

    Draft standard 2024-05

    DIN EN 868-6:2024-05 - Draft

    Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-6:2024

    from 102.10 EUR VAT included

    from 95.42 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 and English version prEN 868-7:2024

    Draft standard 2024-05

    DIN EN 868-7:2024-05 - Draft

    Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-7:2024

    from 115.70 EUR VAT included

    from 108.13 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

    from 121.20 EUR VAT included

    from 113.27 EUR VAT excluded

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  • Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO Technical Specification 16775:2021, second edition, 2021-11)

    Standard [CURRENT] 2023-05-01

    CSA ISO/TS 16775:2023-05-01

    Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO Technical Specification 16775:2021, second edition, 2021-11)

    263.20 EUR VAT included

    245.98 EUR VAT excluded

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