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Publications of ISO/TC 212/WG 2

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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