ISO 15194:2002
In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials
- Standard No.
- ISO 15194:2002
- Release Date
- 2002
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 15194:2009
- Latest
- 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 pro-cedures. 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.
ISO 15194:2002 history
- 2009 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
- 2002 ISO 15194:2002 In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials
