ISO Documents | Standards

CLSI ISO 21151:2020

In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

Published in 2020

CLSI 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

CLSI ISO 17822:2020

In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide

Published in 2020

CLSI ISO/TS 5798:2022

In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods

Published in 2022

CLSI ISO 15197:2013

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

Published in 2013

CLSI ISO 20184-2:2018

ISO 20184-2E Molecular In Vitro Diagnostic Examinations - Specifications For Pre-Examination Processes For Frozen Tissue - Part 2: Isolated Proteins

Published in 2018

CLSI ISO 20186-1:2019

ISO 20186-1E Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 1: Isolated cellular RNA

Published in 2019

CLSI ISO 20186-2:2019

ISO 20186-2E Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 2: Isolated genomic DNA

Published in 2019

CLSI ISO/TS 22583

ISOTS 22583E Guidance for supervisors and operators of point-of-care testing (POCT) devices

Published in 2019

CLSI ISO 15195-2:2018

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

Published in 2018