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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 [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 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023
Edition 2023-08

Standards [CURRENT]

DIN EN 556-1 Berichtigung 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, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006
Edition 2006-12

Standards [CURRENT]

DIN 58948-17

Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources
Edition 2016-10

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

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

Standards [CURRENT]

DIN EN ISO 11138-8

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021); German version EN ISO 11138-8:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 18472

Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018); German version EN ISO 18472:2018
Edition 2018-11

Draft standard

DIN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023
Edition 2023-02

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