YY/T 1709-2020 Translated English of Chinese Standard. (YYT 1709-2020, YY/T1709-2020, YYT1709-2020): Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kitshttps://www.chinesestandard.net, 2020 M11 28 - 31 pages This Standard specifies evaluation methods of measurement uncertainty of calibrators for in vitro diagnostic kits. This Standard is applicable to evaluation of measurement uncertainty of product calibrators for in vitro diagnostic quantitative kits. |
Common terms and phrases
according to formula allowable range specified analysis of variance Beijing bilirubin Bottle 1 Bottle Bottle 2 Day bottle is tested Calculate the relative calculate the uncertainty calibrator assignment calibrator bottles clinical combined standard uncertainty coverage factor expanded uncertainty GB/T group of data historical batch introduced by imprecision introduced by reconstitution introduced by stability introduced by uniformity introduced by valuing long-term stability manufacturer manufacturer's permanent measurement measurement system Measurement uncertainty introduced minimum sampling volume nonuniformity between bottles number of repeated permanent measurement procedures permanent measurement program pipette precision of measurement product calibrator reconstitution stability Relative uncertainty introduced repeatable conditions scheme Second time Third set value smallest packaging unit stability test standard deviation standard measurement uncertainty target uncertainty test results test system Third time Table traceability chain uchar umax uncertainty component introduced uncertainty evaluation introduced uncertainty related uniformity between bottles uniformity between calibrator uREP,rel value traceability valuing process vitro diagnostic kits XX company