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NA 176

DIN Standards Committee Health Technologies

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Projects of NA 176

Number: 529

DIN EN ISO 15193 2021-03-29 In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023 More  Comment 
ISO/FDIS 15194 2021-02-26 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation More  Comment 
ISO/FDIS 15193 2021-02-26 In vitro diagnostic medical devices - Requirements for reference measurement procedures More  Comment 
DIN EN ISO 11137-1 2020-09-21 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024); German version FprEN ISO 11137-1:2024 More  Comment 
DIN EN ISO 11135 2020-07-29 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025); German and English version prEN ISO 11135:2025 More  Comment 
DIN EN ISO 18362 2018-05-30 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  Comment 
DIN EN ISO 18777-1 2018-03-06 Transportable liquid oxygen systems for medical use - Part 1: Common requirements and particular requirements for base units (ISO/FDIS 18777-1:2025); German version FprEN ISO 18777-1:2025 More  Comment 
DIN EN ISO 18777-2 2018-03-06 Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO 18777-2:2025); German version EN ISO 18777-2:2025 More  Comment 
DIN EN 17180 2016-04-18 Sterilizers for medical purposes – Low temperature vaporized hydrogen peroxide sterilizers – Requirements and testing; German version FprEN 17180:2025 More  Comment 

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