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
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.
Legislation related to this standard
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
WITHDRAWN
EN ISO 15193:2009
PUBLISHED
EN ISO 15193:2026
60.60
Standard published
Jul 22, 2026