DSF/prEN ISO 15194
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2007)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 24 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
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.
Document History
June 11, 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
This International Standard specifies requirements for certified reference materials and the content of their supporting documentation for them to be considered as higher order according to ISO...
In vitro diagnostic medical devices – Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)
This standard specifies requirements for producers of CRMs of higher metrological order and the content of their supporting documentation that comply with the requirements of ISO 17511 and the...
DSF/prEN ISO 15194
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2007)
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...
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO/FDIS 15194:2009)
This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order...