YY/T 1183-2010 Translated English of Chinese Standard. (YYT 1183-2010, YY/T1183-2010, YYT1183-2010): Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)https://www.chinesestandard.net, 7.11.2015 - 18 sivua This Standard specifies the general technical requirements for detection reagent (kit) for enzyme-linked immunoabsorbent assay, including terms and definitions, classification, requirements, test methods, labeling, instructions for use, packaging, transportation and storage. |
Sisältö
| 3 | |
Scope | 4 |
Classification | 8 |
Test methods | 11 |
marking labeling and instructions for use | 16 |
Packaging transportation and storage | 18 |
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10-time measurement 10-time measurement results 30-time measurement results analyte batches of reagent Beijing CALCULATE the mean coefficient of variation component of reagent concentration value corresponding specifications cutoff value date of products date to detect detect according detect the accuracy detection reagent kit deviation of 30-time Difference between batches document enzyme-linked immunoabsorbent assay expiry date following contents following methods formula GB/T kits to detect labeling linear range manufacturing enterprise materials DETECT national Mean of 10-time measured value measuring system medical decision level medical devices meet the requirements Metrological traceability Note Number of reference packaging specifications qualitative detection quantitative detection reagent rate of negative rate of positive reagent kits reference materials DETECT reference of detection reference of repeatability requirements of 5.1.3 requirements of corresponding result shall meet sample B solution SD of 10-time Stability The following Stability within expiry standard deviation SD TAKE a reagent test methods Thermal stability test variation CV according