Standard Number: YY/T 1789.4-2022(YY/T1789.4-2022)
Chinese:体外诊断检验系统 性能评价方法 第4部分：线性区间与可报告区间
English:In vitro diagnostic test systems?Performance evaluation method?Part 4: Linear Range And Clinical Reportable Interval
Effective Date:2024-01-01
ICS:11.100
Standard Applicability:This document specifies methods for evaluating the performance of in vitro diagnostic test systems for linear and reportable intervals. This document applies to the performance evaluation of in vitro diagnostic test systems for quantitative determination by the manufacturer. This document does not apply to the performance evaluation of in vitro diagnostic test systems whose results are reported on nominal and ordinal scales, such as in vitro diagnostic test systems used for blood cell identification, microbial typing, nucleic acid sequence identification, and identification of urine particles, and whose results are reported as negative, positive, or 1+, 2+, 3+.
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