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Standard [CURRENT] 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
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from 77.90 EUR VAT included

from 72.80 EUR VAT excluded

Draft standard 2024-03

DIN 58953-9:2024-03 - Draft
Sterilization - Sterile supply - Part 9: Use of re-usable sterilization containers

from 63.80 EUR VAT included

from 59.63 EUR VAT excluded

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

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

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

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

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

Standard [NEW] 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
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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 186.60 EUR VAT included

from 174.39 EUR VAT excluded

Standard [NEW] 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
Online service subscriptions

This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 117.70 EUR VAT included

from 110.00 EUR VAT excluded

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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