UNI EN 12287 : 2001

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
   3.1 Primary measurement standard
   3.2 Secondary measurement standard
   3.3 Matrix (of a material system)
   3.4 Matrix effect
   3.5 Commutability of a material
   3.6 Report
4 Classification and naming of reference materials
   4.1 Description of the properties of reference
        materials
   4.2 System
        4.2.1 Function
        4.2.2 Application and authorities
        4.2.3 Hierarchical position of reference
               materials of higher order in the
               reference measurement system
        4.2.4 Identification code(s)
        4.2.5 Reference material characteristics
   4.3 Component(s)
   4.4 Kind-of-quantity (quantity in a general sense)
   4.5 Numerical value
   4.6 Unit of measurement
   4.7 Construction of systematic designations and
        trivial names
   4.8 Trivial names
   Description
   5.1 Elements of a description
   5.2 Warning and safety precautions
   5.3 Introduction
   5.4 Scope
   5.5 Terminology
        5.5.1 General
        5.5.2 Nomenclature
        5.5.3 Trivial names
   5.6 Justification for choice
   5.7 General characteristics
   5.8 Specific characteristics
   5.9 Validation
        5.9.1 Planning of experimental design
        5.9.2 Assessment of homogeneity
        5.9.3 Statistical evaluation of results
        5.9.4 Assessing the stability
        5.9.5 Value assignment
        5.9.6 Value and uncertainty of measurement
               assigned by one measurement procedure
               in one laboratory
        5.9.7 Regional recognition
   5.10 Intended function
   5.11 Instructions for use
        5.11.1 Safety
        5.11.2 General
        5.11.3 Reagents
        5.11.4 Apparatus
        5.11.5 Environment
        5.11.6 Measuring volumes
        5.11.7 Reconstitution of lyophilized reference
               material
        5.11.8 Reference to patented items
   5.12 Supplier
   5.13 Bibliography
   5.14 Annexes
   5.15 Dates of authorization and revision
6 Label
7 Certificate
8 Package insert
Annex A (informative) Materials with properties other than
        quantities
Annex B (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU directives

Defines requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This standard also provides instruction on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate.