ISO 15193:2026

In vitro diagnostic medical devices — Requirements for reference measurement procedures

OVERVIEW

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

This document applies to:

  1. 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;
  2. any person, body or institution developing RMPs for measurands used in laboratory medicine.

COMMENTS

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PRODUCT DETAILS

Status Current
Edition 2026
No. of Pages 25
ICS Classification 11.100.10 In vitro diagnostic test systems
Committee ISO/TC 212
Available for Purchase For sale in Singapore only
Adoption ISO : 0