Publications of CEN/TC 140

DIN EN ISO 15189 2021-11 Draft standard Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2021); German and English version prEN ISO 15189:2021 More  Order from Beuth Verlag
DIN EN ISO 15189 2014-11 Standards Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15); German version EN ISO 15189:2012 More  Order from Beuth Verlag
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 Beuth Verlag
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 Beuth Verlag
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 Beuth Verlag
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 Beuth Verlag
DIN EN ISO 18113-1 2021-09 Draft standard In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021 More  Order from Beuth Verlag
DIN EN ISO 18113-1 2013-01 Standards In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 More  Order from Beuth Verlag
DIN EN ISO 18113-2 2021-09 Draft standard In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021 More  Order from Beuth Verlag
DIN EN ISO 18113-2 2013-01 Standards In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011 More  Order from Beuth Verlag

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