BAS EN ISO 15193:2011
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
General Information
Status: Published
No. of pages: 23
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 12.05.2011
Technical committee:
Directive:
98/79/EC, In vitro diagnostic medical devices
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 15193:2009, identical
- ISO 15193:2009, identical