Standard Number: YY/T 1789.1-2021(YY/T1789.1-2021)
Chinese:体外诊断检验系统 性能评价方法 第1部分：精密度
English:In vitro diagnostic test systems Evaluation method of performance Part 1: Precision
Effective Date:2023-03-01
ICS:11.100
Standard Applicability:This standard specifies the in vitro diagnostic test system precision performance evaluation method. This standard applies to manufacturers of quantitative in vitro diagnostic test system for precision evaluation. This standard does not apply to the results reported as a nominal scale and ordinal scale in vitro diagnostic test system performance evaluation, such as for blood cell identification, microbial typing, nucleic acid sequence identification, urine particle identification, the results are reported as negative, positive or 1 +, 2 +, 3 + in vitro diagnostic test system. This standard does not apply to medical laboratory precision performance verification, nor does it apply to product type inspection.
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