WS/T 253-2005 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Description of reference materials (English Version)
This standard specifies the requirements and format for the description of reference materials. Reference materials suitable for higher levels of metrology. These reference materials can be classified into primary measurement standards and secondary measurement standards, which serve as calibrators or quality control materials for reference measurement procedures. This standard does not apply to reference materials that are part of in vitro diagnostic measurement systems. This standard also explains how to collect basic data to determine a value and how to issue an assignment. This standard also specifies the certificate format. This standard does not apply to the production of reference materials.
WS/T 253-2005 Referenced Document
EN 375:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
WS/T 253-2005 history
2005WS/T 253-2005 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Description of reference materials