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Publications of CEN/TC 140

DIN EN ISO 18153 2003-11 Standards In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003 More  Order from Beuth Verlag
DIN EN ISO 19001 2013-07 Standards In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 More  Order from Beuth Verlag
DIN EN ISO 20776-1 2020-12 Standards Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12); German version EN ISO 20776-1:2020 More  Order from Beuth Verlag
DIN EN ISO 20776-2 2022-04 Standards Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021); German version EN ISO 20776-2:2022 More  Order from Beuth Verlag
DIN EN ISO 20916 2021-05 Draft standard In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 More  Order from Beuth Verlag
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 Beuth Verlag
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 Beuth Verlag

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