dnaSRPS EN ISO 15193:2022

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

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.