YY/T 1175-2010 Translated English of Chinese Standard. (YYT 1175-2010, YY/T1175-2010, YYT1175-2010): Quantitative detection reagent (kit) for tumor markers - Chemiluminescent immunoassayhttps://www.chinesestandard.net, 2014 M12 8 - 15 pages This standard specifies the terms and definition, classification, requirements, test method, marks, labels, instructions, packaging, transportation and storage etc. of quantitative detection reagent (kit) for tumor markers (chemiluminescent immunoassay). This standard applies to the reagent (kit) used for quantitative detection of human tumor markers taking the chemiluminescent immunoassay as the principle. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) in the carrier of micro-plates, tubes, magnetic particles, micro-beads and plastic beads. This standard does not apply to: a) The calibrator and quality control product of tumor markers intended for separate sale; b) Biochip that uses chemiluminescent immunoassay as the principle. |
Contents
| 3 | |
Scope | 4 |
Classification | 8 |
Test Methods | 10 |
Marks labels and instructions | 12 |
Packaging transportation and storage | 14 |
| 15 | |
Common terms and phrases
accordance with requirements after-sales service organization based on Formula batches of reagent Beijing chemiluminescent immunoassay reagent China Clinical Laboratory China SAC/TC 136 Coefficient of variation comply correlation coefficient corresponding to cM+2SD detect the accuracy detection in accordance detection reagent kit device registration certificate document enterprise or after-sales following contents GB/T immunoassay reagent kits Instructions of reagent instrument-automatic operation method least the following linear range manual operation method manufacturing enterprise mean value measurement results measurement system Medical device registration Metrological traceability micro-beads and plastic minimum detection limit Modify ISO/FDIS national standard material non-enzymatic chemiluminescent immunoassay Note obtained and based packaging specifications perform the detection Product batch number Product name Product standard number Quantitative detection reagent registration certificate number relative deviation requirements of 5.3 RLU value corresponding Shanghai share-amount specified standard deviation SD Take the reagent Terms and definitions thermal stability conditions Thermal stability test Tumor marker sample variation CV Within-batch difference zero-concentration calibrator