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 (English Version)

Standard No.

GB/T 21415-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 21415-2008

Scope

This standard specifies the method for confirming the metrological traceability of the assignment of calibrators and control substances for the purpose of establishing or confirming the correctness of measurement. Calibrators and control substances are supplied by the manufacturer as part of or used with in vitro diagnostic medical devices. The external quality evaluation samples that are assigned by the internationally recognized reference measurement system or the internationally recognized conventional reference measurement system and have been proven to be interchangeable are applicable to this standard. This standard does not apply to: a) Control substances that have no assigned value and are only used to evaluate the precision of a measurement procedure, that is, its repeatability or reproducibility (precision control substances); b) Control substances used for quality control in the laboratory Controlled substances, such substances have recommended acceptable result value intervals, which are formulated by different laboratories for a specific measurement procedure agreement, and their limit values have no metrological traceability; c) Measure the same amount at the same measurement level The measurement results of two measurement procedures are correlated, but such "level" correlation does not provide metrological traceability; d) calibration is performed by the correlation between the results of two measurement procedures at different e) routine results can be traced to the metrological traceability of product calibrators and their relationship to medical judgment limits; f) properties related to nominal scale, that is, properties without magnitude (such as blood cell classification).

GB/T 21415-2008 Referenced Document

• EN 375:2001 Information Supplied by the manufacturer with in Vitro Diagnostic Reagents for Professional Use
• GB/T 19702-2005 In vitro diagnostic medical devices.Measurement of quantities in samples of biological origin.Presentation of reference measurement procedures
• GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials

GB/T 21415-2008 history

• 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