EN ISO 15193:2026

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO 15193:2026) EN ISO 15193:2026

Publication date:   Jun 21, 2026

General information

60.60   Standard published   Jul 22, 2026

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

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.

Related legislation

Legislation related to this standard

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15193:2009

NOW

PUBLISHED
EN ISO 15193:2026
60.60 Standard published
Jul 22, 2026




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