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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 [New]

DIN EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024
Edition 2024-09

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 13408-6

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021); German version EN ISO 13408-6:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 15883-1

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014
Edition 2014-10

Draft standard

DIN EN ISO 18362

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018
Edition 2018-11

Standards [CURRENT]

DIN EN ISO 11139

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024
Edition 2024-06

Draft standard

DIN EN ISO 15883-1

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020); German and English version prEN ISO 15883-1:2020
Edition 2021-01

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