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Standards [CURRENT]

DIN EN ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
Edition 2010-03

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

Standards [CURRENT]

DIN 58953-6

Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Edition 2023-11

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

Standards [CURRENT]

DIN EN 16602-70-53

Space product assurance - Materials and hardware compatibility tests for sterilization processes; English version EN 16602-70-53:2015
Edition 2015-05

Indikatoren und Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte
Edition 2020-12

Niedertemperatur-Sterilisation - Anforderungen an Verfahren, Geräte und zugehörige Ausrüstung
Edition 2020-12

Horizontale Europäische Normen in Anlehnung an entsprechende EU-Richtlinien und -Verordnungen
Edition 2022-06

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