Over deze norm
||In vitro diagnostica
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.
||In-vitro-diagnostische systemen - Meting van grootheden in monsters van biologische oorsprong - Beschrijving van referentiematerialen
||In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials