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ISO 15193:2026

In vitro diagnostic medical devices — Requirements for reference measurement procedures

Publication date:   Jun 18, 2026

General information

60.60   Standard published   Jun 18, 2026

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

This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:

RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15193:2009

NOW

PUBLISHED
ISO 15193:2026
60.60 Standard published
Jun 18, 2026