Standard No.:	YY/T 1789.6-2023
English Name:	In vitro diagnostic test systems―Performance evaluation method―Part 6:Precision, diagnostic sensitivity and specificity of qualitative reagents
Chinese Name:	体外诊断检验系统性能评价方法第6部分：定性试剂的精密度、诊断灵
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Source Content Issued by:	State Drug Administration
Issued on:	2023-01-13
Implemented on:	2024-1-15
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	225.0
Delivery:	via email in 1~3 business day

本文件规定了体外诊断检验系统定性试剂的精密度、诊断灵敏度和特异性的性能评价方法。
本文件适用于制造商对定性检验的体外诊断检验系统的精密度、诊断灵敏度和特异性评价。
本文件不适用于结果报告为半定量的体外诊断检验系统的性能评价。
本文件不适用于医学实验室的性能验证，也不适用于产品型式检验。