YY/T 1193-2011 Translated English of Chinese Standard. (YYT 1193-2011, YY/T1193-2011, YYT1193-2011): Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay)https://www.chinesestandard.net, 2014 M12 8 - 12 pages This standard specifies the product classification, requirements, test method, marks, labels, instructions, packaging, transportation and storage etc. of the follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay). This standard is applicable to follicle stimulating hormone (FSH) kit of quantitative detection in human blood matrix or other body fluid components, based on the principle of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection kit in the carriers of micro-plates, pipes, magnetic particles, micro-beads and plastic beads. This standard does not apply to: a) The calibrator and quality control product of follicle stimulating hormone intended for separate sale; b) Biochip that uses the principle of chemiluminescent immunoassay. |
Common terms and phrases
10-times measured results according to Formula accuracy after-sales service organization allowable concentration deviation average value cM batches of kits Beijing Calculate the mean chemiluminescent immunoassay kits coefficient of variation detection according detection result deviation is 20 deviation of 20 follicle stimulating hormone following contents FSH kit FSH sample containing immunoassay kit chemiluminescent instrument-automatic operation method IU/L concentration deviation IU/L its allowable least the following linear range lower than 20 manual operation method manufacturing enterprise mean value CM Medical device registration meet the requirements methods in 5.3 micro-beads and plastic minimum detection limit non-enzymatic chemiluminescent immunoassay packaging specifications perform the detection principle of chemiluminescent Product batch number Product names Product standard number recovery rate registration certificate number relative deviation repeat the detection requirements in 4.3 Respectively repeat result shall comply standard deviation SD stimulating hormone FSH Storage conditions Thermal stability test Traceability validity is place zero-concentration calibrator zero-concentration FSH sample