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Standards [CURRENT]

DIN EN 17141

Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020
Edition 2021-02

Standards [CURRENT]

DIN EN ISO 15378

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
Edition 2018-04

Standards [CURRENT]

DIN EN ISO 80601-2-61

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 80601-2-61:2019
Edition 2019-09

Draft standard

DIN EN 17915

Chemical disinfectants and antiseptics - Quantitative carrier test method for the evaluation of virucidal activity of chemical disinfectants on hard non-porous surfaces in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 2); German and English version prEN 17915:2022
Edition 2022-11

Draft standard

DIN EN 17914

Chemical disinfectants and antiseptics - Quantitative suspension test method for the evaluation of virucidal activity of chemical disinfectants and antiseptics in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1); German and English version prEN 17914:2022
Edition 2022-11

Standards [CURRENT]

DIN EN ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006
Edition 2006-11

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

Standards [CURRENT]

DIN EN ISO 13408-2

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018
Edition 2018-06

Standards [CURRENT]

DIN EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015
Edition 2015-12

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

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