SS-EN-ISO-15194 › In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
SS-EN-ISO-15194
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2009 EDITION
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CURRENT
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This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 15194:2009
Revision Level
2009 EDITION
Status
Current
Publication Date
May 25, 2009
Language(s)
English
Page Count
32
International Equivalent
EN ISO 15194:2009(IDT); ISO 15194:2009(IDT)