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Standards [CURRENT]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
Edition 2022-09

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

Standards [CURRENT]

DIN EN ISO 11737-1

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021
Edition 2021-10

Draft standard

DIN EN 17180

Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
Edition 2023-03

Draft standard

DIN EN ISO 25539-3

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS 25539-3:2023); German and English version prEN ISO 25539-3:2023
Edition 2023-08

Standards [CURRENT]

DIN EN ISO 17664-2

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023
Edition 2024-04

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 EN ISO 22442-1

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020
Edition 2021-08

Draft standard [New]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
Edition 2024-08

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

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