I.S. EN ISO 15194:2009
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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