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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 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023
Edition 2023-08

Standards [CURRENT]

DIN EN ISO 14160

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020); German version EN ISO 14160:2021
Edition 2021-11

Standards [CURRENT]

DIN EN 16604-20

Space sustainability - Planetary protection; English version EN 16604-20:2020
Edition 2021-09

Standards [CURRENT]

DIN EN ISO 13408-2

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018
Edition 2018-06

Standards [CURRENT]

DIN EN ISO 20857

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
Edition 2013-08

Standards [CURRENT]

DIN EN ISO 11138-7

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019
Edition 2019-11

Draft standard

DIN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023
Edition 2023-05

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

Draft standard [New]

DIN EN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
Edition 2024-04

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