ISO Documents | Standards

CLSI ISO 23162:2021

Basic semen examination — Specification and test methods

Published in 2021

CLSI ISO 35001:2019

Biorisk Management for Laboratories and Other Related Organizations

Published in 2019

CLSI ISO 15198:2004

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

Published in 2004

CLSI ISO/TS 16782:2016

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

Published in 2016

CLSI 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

CLSI ISO 20776-2:2021

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

Published in 2021

CLSI 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

CLSI ISO 20916:2019

In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice

Published in 2019

CLSI ISO 23640:2011

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

Published in 2011

CLSI ISO 18113-1:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements

Published in 2022