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Standards Worldwide
Standards Worldwide
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Medizintechnik

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Standard [CURRENT] [PLEASE NOTE THE WARNING NOTICE] 2023-11

DIN 58953-6:2023-11
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Please note the warning notice (PDF)

from 77.90 EUR VAT included

from 72.80 EUR VAT excluded

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Standard [NEW] 2024-10

DIN 58953-9:2024-10
Sterilization - Sterile supply - Part 9: Use of re-usable sterilization containers; Text in German and English

from 63.80 EUR VAT included

from 59.63 EUR VAT excluded

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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 99.10 EUR VAT included

from 92.62 EUR VAT excluded

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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 99.10 EUR VAT included

from 92.62 EUR VAT excluded

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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 85.30 EUR VAT included

from 79.72 EUR VAT excluded

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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 99.10 EUR VAT included

from 92.62 EUR VAT excluded

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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 112.30 EUR VAT included

from 104.95 EUR VAT excluded

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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 186.60 EUR VAT included

from 174.39 EUR VAT excluded

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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 117.70 EUR VAT included

from 110.00 EUR VAT excluded

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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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