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Standards [CURRENT]

DIN EN ISO 8871-4

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); German version EN ISO 8871-4:2006
Edition 2006-09

Standards [CURRENT]

DIN EN ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006
Edition 2006-11

Standards [CURRENT]

DIN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019
Edition 2020-04

Standards [CURRENT]

DIN EN ISO 25424

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019 + A1:2022
Edition 2022-07

Standards [CURRENT]

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 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
Edition 2020-04

Draft standard

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/DIS 17665:2022); German and English version prEN ISO 17665:2022
Edition 2022-11

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 [CURRENT]

DIN EN 14683

Medical face masks - Requirements and test methods; German version EN 14683:2019+AC:2019
Edition 2019-10

Standards [CURRENT]

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 version EN 556-1:2001
Edition 2002-03

Standards [CURRENT]

DIN EN ISO 21322

Cosmetics - Microbiology - Testing of impregnated or coated wipes and masks (ISO 21322:2020); German version EN ISO 21322:2021
Edition 2022-05

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