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SSH EN ISO 15194:2009

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)

Oct 31, 2011

General information

60.60     Oct 31, 2011

DPS

DPS/KT 140

European Norm

11.100.10  

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Scope

ISO 15194:2009 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. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 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.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized

Life cycle

PREVIOUSLY

Replaces
SSH EN 12287:2002

NOW

PUBLISHED
SSH EN ISO 15194:2009
60.60 Standard published
Oct 31, 2011

Related project

Adopted from EN ISO 15194:2009

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