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Standards [CURRENT]

DIN EN 285

Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
Edition 2021-12

Standards [CURRENT]

DIN EN ISO 11140-6

Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (ISO 11140-6:2022); German version EN ISO 11140-6:2022
Edition 2023-02

Standards [CURRENT]

DIN EN 12297

Biotechnology - Equipment - Guidance on testing procedures for sterilizability; German version EN 12297:1998
Edition 1998-05

Standards [CURRENT]

DIN EN ISO 17665

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024); German version EN ISO 17665:2024
Edition 2024-09

Standards [New]

DIN 58953-9

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

Standards [CURRENT]

DIN EN ISO 11607-1

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
Edition 2024-02

Standards [CURRENT]

DIN 58951

Sterilization - Steam sterilizers for laboratory use - Apparatus requirements, requirements on services and installation
Edition 2024-07

Standards [CURRENT]

DIN 58950-1

Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Vocabulary; Text in German and English
Edition 2022-06

Standards [CURRENT]

DIN EN ISO 11607-2

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
Edition 2024-02

Standards [CURRENT]

DIN 58950-7

Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English
Edition 2022-06

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