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Publications of CEN/TC 140

DIN EN ISO 5649 2024-02 Draft standard Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023 More  Order from DIN Media
DIN EN ISO 6710 2017-12 Standards Single-use containers for human venous blood specimen collection (ISO 6710:2017); German version EN ISO 6710:2017 More  Order from DIN Media
DIN EN ISO 6717 2021-12 Standards In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021); German version EN ISO 6717:2021 More  Order from DIN Media
DIN EN ISO 15189 2024-08 Standards Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022 + A11:2023 More  Order from DIN Media
DIN EN ISO 15193 2009-10 Standards In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); German version EN ISO 15193:2009 More  Order from DIN Media
DIN EN ISO 15194 2009-10 Standards In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); German version EN ISO 15194:2009 More  Order from DIN Media
DIN EN ISO 15195 2019-07 Standards Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018); German version EN ISO 15195:2019 More  Order from DIN Media
DIN EN ISO 15197 2015-12 Standards In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015 More  Order from DIN Media
DIN EN ISO 16256 2022-02 Standards Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021); German version EN ISO 16256:2021 More  Order from DIN Media
DIN EN ISO 17511 2021-11 Standards In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021 More  Order from DIN Media

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