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NEN-EN 12287

In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials

inactive
Organization: NEN
Publication Date: 1 February 1996
Status: inactive
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

Specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, such as primary measurement standards, secondary measurement standard and reference measurement standards, and to materials of lower order, such as working standards. It also specifies requirements for the package insert associated with a reference material. The description of a reference material in accordance with this standard does not necesarrily of itself constitute an european standard or an european prestandard. It may be stated, however, that the documentation of its metrological quality and description is in accordance with this standard. This standard also provides guidance on how to collect basic data for value assignment and it guides the evaluation and presentation of the assigned value. The standard also specifies the format for a certificate. This standard is not applicable to the production of the reference materials.

Document History

July 1, 1999
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
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...
October 1, 1997
In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials
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...
NEN-EN 12287
February 1, 1996
In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials
Specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, such as primary measurement standards, secondary...
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