YY/T 1789.3-2022 Active Industry standards-Medicine

YY/T 1789.3-2022 In vitro diagnostic test systems—Performance evaluation method—Part 3:Limit of detection and limit of quantitation

Publish Date: 2022-07-01 Implement Date: 2024-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1789.3-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2022-07-01

Implement Date: 2024-01-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)

Pages: 36 pages

Scope

本文件规定了体外诊断检验系统的检出限与定量限性能评价方法。
本文件适用于制造商对定量测定的体外诊断检验系统进行性能评价。
本文件不适用于结果报告为名义标度和序数标度的体外诊断检验系统的性能评价，例如用于血细胞鉴定、微生物分型、核酸序列鉴定、尿液颗粒鉴定，结果报告为阴性、阳性或1+、2+、3+的体外诊断检验系统。