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Publications of CEN/TC 204

DIN EN ISO 13408-7 2015-11 Standards Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015 More  Order from DIN Media
DIN EN ISO 14160 2021-11 Standards Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020); German version EN ISO 14160:2021 More  Order from DIN Media
DIN EN ISO 14937 2010-03 Standards 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 More  Order from DIN Media
DIN EN ISO 17664-1 2021-11 Standards Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021 More  Order from DIN Media
DIN EN ISO 17665 2022-11 Draft standard 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 More  Order from DIN Media
DIN EN ISO 17665-1 2006-11 Standards 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 More  Order from DIN Media
DIN EN ISO 18362 2018-11 Draft standard Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018 More  Order from DIN Media
DIN EN ISO 20857 2013-08 Standards 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 More  Order from DIN Media
DIN EN ISO 25424 2022-07 Standards Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019 + A1:2022 More  Order from DIN Media
DIN ISO/TS 17665-2 2009-07 Technical Specification Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009 More  Order from DIN Media

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