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Publications of ISO/TC 212/WG 2

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DIN EN ISO 15193	2024-02	Draft standard	In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023 More	Order from DIN Media
DIN EN ISO 15194	2024-02	Draft standard	In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023 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 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
ISO/TS 20914	2019-07	Pre-standard	Medical laboratories - Practical guidance for the estimation of measurement uncertainty More	Order from DIN Media
ISO 15193	2009-05	Standards	In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures More	Order from DIN Media
ISO 15194	2009-05	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 More	Order from DIN Media
ISO 15195	2018-12	Standards	Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures More	Order from DIN Media
ISO 17511	2020-04	Standards	In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples More	Order from DIN Media
ISO 18153	2003-08	Standards	In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials More	Order from DIN Media

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