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ISO 15193:2009

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

Publication date:   Apr 28, 2009

General information

90.92 Standard to be revised   Dec 4, 2020

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.10   In vitro diagnostic test systems

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Scope

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.
ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15193:2002

NOW

PUBLISHED
ISO 15193:2009
90.92 Standard to be revised
Dec 4, 2020

REVISED BY

IN_DEVELOPMENT
ISO/FDIS 15193