YY/T 1652-2019 Translated English of Chinese Standard. (YYT 1652-2019, YY/T1652-2019, YYT1652-2019): General technical requirements of quality control materials for in vitro diagnostic reagentsThis 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. |
Contents
| 3 | |
Scope | 4 |
Terms and definitions | 5 |
Requirements | 6 |
Test methods | 8 |
Labels and instructions for use | 15 |
Appendix A Informative Study principles for control material valuing matrix effect and biosafety | 16 |
| 18 | |
Common terms and phrases
15 minimum package acceptable intervals/values/measurement signal applicable verification methods biosafety claimed thermal stability date is detected detected according diagnostic medical devices end of unsealing/redissolving expiration date extract the quality following methods formula 17 homogeneity human sample in-bottle inspection method intervals/values/measurement signal values manufacturer must explain manufacturer’s claimed thermal Matrix effect measurement is repeated measurement signal values meet the requirements methods for verification minimum package units negative/positive results newly-unsealed/redissolved quality control Non-numerical quality control Note Number of measurements Numerical quality control order of priority Packing volumes period to detect provide applicable verification quality control material Randomly extract reasons and provide relative deviation requirements of 4.4 requirements of 4.5.1 result shall meet Shanghai specified storage conditions specify the stability stability study data stability The manufacturer standard deviation suitable for method TAKE the quality thermal stability method thermal stability period unsealing/redissolving stability period values are suitable vitro diagnostic medical vitro diagnostic reagents