UNI EN 12287 : 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS
09-03-2009
01-01-2001
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
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