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SRPS EN ISO 15193:2026

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

Sep 30, 2026

General information

60.60     Sep 30, 2026

ISS

Z076

European Norm

11.100.10  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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WITHDRAWN
SRPS EN ISO 15193:2011

NOW

PUBLISHED
SRPS EN ISO 15193:2026
60.60 Standard published
Sep 30, 2026

Related project

Adopted from EN ISO 15193:2026 IDENTICAL

Adopted from ISO 15193:2026 IDENTICAL