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Standards [CURRENT]

DIN EN ISO 11138-2

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017
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

Draft standard

DIN EN ISO 22610

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO/DIS 22610.2:2017); German and English version prEN ISO 22610:2017
Edition 2017-05

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 14583

Workplace exposure - Volumetric bioaerosol samplers - General requirements and evaluation of performance; German version EN 14583:2021
Edition 2022-02

Standards [CURRENT]

DIN 58953-6

Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Edition 2023-11

Draft standard [New]

DIN EN 12469-2

Biological safety cabinets - Part 2: BSC class II; German and English version prEN 12469-2:2024
Edition 2024-07

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 17141

Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020
Edition 2021-02

Standards [CURRENT]

DIN EN ISO 11138-1

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017
Edition 2017-07

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