GB/T 21415-2008 Replaced National standards

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

Publish Date: 2008-01-22 Implement Date: 2008-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 21415-2008

Standard Type: National standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2008-01-22

Implement Date: 2008-09-01

Pages: 28 pages

Scope

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.