I.S. EN 12287:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
15-09-2009
English
01-01-1999
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.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and naming of reference materials
5 Description of a reference material
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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