This Standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation, and storage of quality control materials for in vitro diagnostic reagents. This Standard applies to quality control materials intended for the quality control of adapted reagents. This Standard does not apply to: a) Quality control materials for correctness verification; b) Quality control materials for external quality assessment; c) Quality control materials for the detection of microorganisms, immunohistochemistry, molecular pathology, morphology, etc.; d) Except for the above circumstances, if still inapplicable, the manufacturer must provide a reason.
Basic Data
Standard ID
YY/T 1652-2019 (YY/T1652-2019)
Description (Translated English)
General technical requirements of quality control materials for in vitro diagnostic reagents
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
14,115
Date of Issue
2019
Date of Implementation
2020-06-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of quality control substances for in vitro diagnostic reagents. This standard applies to the quality control substances expected to be used for the quality control of aptamer reagents. This standard does not apply to: quality control materials for correctness verification; quality control materials for inter-laboratory quality evaluation; quality control materials for microbiology, immunohistochemistry, molecular pathology, morphology, etc.; If the above situation is still not applicable, the manufacturer needs to provide reasons.
