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EN ISO 15193:2009

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

Publication date:   Aug 20, 2010

General information

90.92 Standard to be revised   Sep 3, 2014

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.10   In vitro diagnostic test systems

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Scope

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.
ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC

Life cycle

NOW

PUBLISHED
EN ISO 15193:2009
90.92 Standard to be revised
Sep 3, 2014

REVISED BY

IN_DEVELOPMENT
prEN ISO 15193