• Hydrogen Technologies Standards form the basic framework for market ramp-up

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  • Climate change Standards and specifications support climate targets

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  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

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Publications of NA 176-03-09 AA

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 17664-2 2024-04 Standards Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023 More  Order from DIN Media
DIN EN ISO 17665 2024-09 Standards Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024); German version EN ISO 17665:2024 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
ISO/TS 11137-4 2020-06 Pre-standard Sterilization of health care products - Radiation - Part 4: Guidance on process control More  Order from DIN Media
ISO/TS 19930 2017-12 Pre-standard Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10⁻⁶ More  Order from DIN Media
ISO/TS 21387 2020-09 Pre-standard Sterilization of medical devices - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release More  Order from DIN Media
ISO/TS 22456 2021-03 Pre-standard Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products More  Order from DIN Media
ISO 11135 2014-07 Standards Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More  Order from DIN Media

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