EN 12287:1999

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

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Aug 11, 2009

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100   Laboratory medicine

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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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 12287:1999
99.60 Withdrawal effective
Aug 11, 2009