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Standards [CURRENT]

DIN EN ISO 13004

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022); German version EN ISO 13004:2023
Edition 2023-10

Standards [CURRENT]

DIN EN ISO 11138-5

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017
Edition 2017-07

Standards [CURRENT]

DIN EN ISO 11138-4

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
Edition 2017-07

Standards [CURRENT]

DIN EN ISO 11737-2

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020
Edition 2020-07

Standards [CURRENT]

DIN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015
Edition 2015-11

Standards [CURRENT]

DIN EN ISO 11140-1

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014
Edition 2015-03

Standards [CURRENT]

DIN EN 285

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

Standards [New]

DIN EN ISO 11139

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024
Edition 2024-06

Draft standard

DIN EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023
Edition 2023-02

Standards [Pre-order]

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

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