ISO Documents | Standards

ISO 15189:2022

Medical laboratories — Requirements for quality and competence

Published in 2022

ISO 15190-Ed2:2020

Medical laboratories — Requirements for safety, 2nd Edition

Published in 2020

ISO 15193:2009

In vitro diagnostic systems — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures

Published in 2009

ISO 15194:2009

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation

Published in 2009

ISO 15195-2:2018

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures

Published in 2018

ISO 15197:2013

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Published in 2013

ISO 15198:2004

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

Published in 2004

ISO 16256:2021

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

Published in 2021

ISO 17511-Ed2:2020

In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples, 2nd Edition

Published in 2020

ISO 17593:2022

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Published in 2022