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

Synopsis

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.

Comments

General Information

Status Current
Edition 2009
No. of Pages 19
ICS Classification 11.100.10 In vitro diagnostic test systems
Committee ISO/TC 212
Available for Purchase For sale in Singapore only
Adoption ISO