Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-7:2024
Edition 2024-05

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

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3:2017
Edition 2017-05

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

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

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German and English version prEN 868-3:2024
Edition 2024-05

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
Edition 2009-10

Cleanliness of medical devices - Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods; Text in German and English
Edition 2022-04

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
Edition 2023-07

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021); German version CEN ISO/TS 16775:2021
Edition 2022-04