YY/T 0638-2008
In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials (English Version)
- Standard No.
- YY/T 0638-2008
- Language
- Chinese, Available in English version
- Release Date
- 2008
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 0638-2008
- Scope
- This standard specifies methods to ensure the metrological traceability of assigned values to enzyme catalytic concentration calibrators and control substances. These calibrators and control materials are intended for use in establishing or verifying the accuracy of enzyme catalytic concentration measurements and are provided by the manufacturer as part of or in combination with an in vitro diagnostic medical device. This standard does not apply to: a) Requirements for the design or selection of reference measurement procedures; b) Enzyme quality or quantities involved in enzyme immunoreactivity; c) No assignment, only used to evaluate the precision of the measurement procedure, that is, repeatability or reproducibility. (precision control substances); d) control substances intended for use in indoor quality control, which have recommended intervals of acceptable result values established by agreement between different laboratories for a defined measurement procedure , whose limits are not metrologically traceable; e) metrological traceability of conventional products to product calibrators, and its relationship with medical judgment limits; f) characteristics related to nominal and ordinal scales.
YY/T 0638-2008 history
- 2008 YY/T 0638-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
