ISO Documents | Standards

ISO/TS 16766

Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

Published in 2024

ISO 22367:2020

Medical laboratories — Application of risk management to medical laboratories

Published in 2020

ISO 5649Ed1

Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed tests

Published in 2024

ISO/TS 23824:2024

Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology

Published in 2024

ISO/TS 20914:2019

Medical laboratories — Practical guidance for the estimation of measurement uncertainty

Published in 2019

ISO/TS 17518:2015

Medical laboratories — Reagents for staining biological material — Guidance for users

Published in 2015

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

ISO15189WR

Medical Laboratories—Requirements for Quality and Competence: Changes from the Third Edition (2012) to the Fourth Edition (2022) Webinar

ISO 20166-1:2018

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA

Published in 2018