GB/T 21415-2008
GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
Abstract
This standard specifies the method for confirming the metrological traceability of calibration products and control substances used for establishing or confirming the accuracy of measurements. Calibration products and control substances are provided by manufacturers as part of or for use with in vitro diagnostic medical devices. Interlaboratory quality evaluation samples that have been proven to be interchangeable and are assigned values by internationally recognized reference measurement systems or internationally recognized agreed reference measurement systems are applicable to this standard.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Replaced |
| Standard Code | GB/T 21415-2008 |
| CCS | Medical laboratory equipment |
| ICS | Laboratory medicine |
| Implement Date | 2008-09-01 |