ISO-15193 › In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
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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.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
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Document Number
ISO 15193:2009
Revision Level
2ND EDITION
Status
Current
Publication Date
May 1, 2009
Committee Number
ISO/TC 212