prBAS EN ISO 15193:2027

In vitro diagnostic medical devices - Requirements for reference measurement procedures


General information
Status:Project
Number of pages:31
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:22.10.2026
Forseen date for next stage code:31.10.2026
Technical committee:BAS/TC 25, Healthcare
ICS:
11.100.10, In vitro diagnostic test systems

Abstract
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.

Lifecycle
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Original document and degree of correspondence
EN ISO 15193:2026, identical
ISO 15193:2026, identical

Relation to BAS standards

Work material

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