BAS EN 12287:2002
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
General Information
Status: Withdrawn
No. of pages: 20
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 08.10.2002
Technical committee:
Directive:
98/79/EC, In vitro diagnostic medical devices
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Abstract
This European Standard specifies 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 European Standard also provides instructions 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. This European Standard is not applicable to the production of the reference materials.
Lifecycle
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Original document and degree of correspondence
- EN 12287:1999, identical