BS EN 12287:1999
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials

Standard No.
BS EN 12287:1999
Release Date
1999
Published By
British Standards Institution (BSI)
Status
 2009-05
Replace By
BS EN ISO 15194:2009
Latest
BS EN ISO 15194:2009
Scope
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.

BS EN 12287:1999 history

  • 2009 BS EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
  • 1999 BS EN 12287:1999 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials



Copyright ©2024 All Rights Reserved