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ISO 15193:2026
In vitro diagnostic medical devices - Requirements for reference measurement procedures
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.
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International Organization for Standardization [iso]
