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

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Basic Data

Standard ID	GB/T 21415-2008 (GB/T21415-2008)
Description (Translated English)	In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	24,276
Date of Issue	2008-01-22
Date of Implementation	2008-09-01
Quoted Standard	GB/T 19702-2005; GB/T 19703-2005; EN 375; ISO GUIDE 35-1989
Adopted Standard	ISO 17511-2003, IDT
Regulation (derived from)	National Standard Approval Announcement 2008 No.2 (Total No.115)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard provides for the measure to establish or confirm the accuracy of the calibration products for the purpose of controlled substances and methods of metrological traceability assignment for confirmation. Calibrators and control materials provided by the manufacturer, used together as part of its in vitro diagnostic medical devices. Recognized by the international reference measurement system or internationally recognized conventions reference measurement system assignment, has proven quality assessment of interchangeability between samples applicable to this standard.