YY/T 1582-2018: Translated English of Chinese Standard. (YYT 1582-2018, YY/T1582-2018, YYT1582-2018): Colloidal gold immunochromatography readerThis standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of colloidal gold immunochromatography analyzers. This standard is applicable to instruments that interpret the results of samples by measuring the reflectivity of the bands in the reaction zone of the colloidal gold reagent card. This standard does not apply to instruments that use fluorescent labels or other labeling methods for rapid immunoassay. |
What people are saying - Write a review
We haven't found any reviews in the usual places.
Common terms and phrases
according to formula actual Appearance applicable area frame average block for metering calculate the relative channel choose clearly clinical coefficient of variation concentration control and laboratory correlation coefficient difference document electrical equipment enterprise equal equipment for measurement Figure A.1 filling setting following methods Function greater indicate Instruction manual issue Labels least less linear range linear regression manufacturer marked matching reagent test measurement gray block measurement results medical decision level Medical Device meet the requirements metering calibration method of quality method specified minimum value operation packaging Preparation Production date quality control strip reagent test sample reference reflectivity measurement reflectivity range reflectivity value relative deviation relative range requirements of GB/T Resolution respectively RGB setting value Safety requirements Scale shown in Figure standard reflectivity whiteboard storage surface Table test methods Test quality control Test the quality Traceability transportation variation CV
Bibliographic information
| Title | YY/T 1582-2018: Translated English of Chinese Standard. (YYT 1582-2018, YY/T1582-2018, YYT1582-2018): Colloidal gold immunochromatography reader |
| Author | https://www.chinesestandard.net |
| Publisher | https://www.chinesestandard.net, 2021 |
| Length | 19 pages |
| Subjects | › Law / Administrative Law & Regulatory Practice Law / Medical Law & Legislation Medical / General Medical / Instruments & Supplies Technology & Engineering / Measurement |
| Export Citation | BiBTeX EndNote RefMan |