Publications of CEN/TC 140

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DIN EN ISO 20916 2024-07 Standards In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024 More  Order from DIN Media
DIN EN ISO 22367 2020-09 Standards Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020); German version EN ISO 22367:2020 More  Order from DIN Media
DIN EN ISO 22367 2025-05 Draft standard Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22367:2025); German and English version prEN ISO 22367:2025 More  Order from DIN Media
DIN EN ISO 23640 2026-07 Draft standard In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO/DIS 23640:2026); German and English version prEN ISO 23640:2026 More  Read draft and comment
DIN EN ISO 23640 2015-12 Standards In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 More  Order from DIN Media

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