EN ISO 15194:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Systematic format of properties in the supporting
  documentation of a certified reference material
  4.1 Format of properties
  4.2 Construction of systematic designations
  4.3 Trivial names
5 Properties, production, and characterization of a
  certified reference material
  5.1 Hierarchical position
  5.2 Properties
  5.3 Production and characterization
6 Content of supporting documentation
  6.1 Supporting documentation
  6.2 Label
  6.3 Certificate
  6.4 Certification report
Annex A (informative) - Certified reference materials
        with nominal properties or ordinal quantities
Bibliography
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 98/79

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.