标准编号：ISO/TS 17822-1:2014
中文名称：体外诊断检验系统 微生物病原体的检测和识别用基于核酸的体外定性检验程序 第1部分：一般要求、术语和定义
英文名称：In vitro diagnostic test systems — Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens — Part 1: General requirements, terms and defi
发布日期：2014-12
标准范围
This Technical Specification is intended for— IVD medical device manufacturers, medical laboratories, and research and development laboratoriesthat develop nucleic acid-based qualitative in vitro diagnostic examination procedures for thedetection and identification of microbial pathogens in human specimens, and— medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for thedetection and identification of microbial pathogens in human specimens.This part of ISO/TS 17822 does not apply to— nucleic acid-based examinations that are not intended for in vitro diagnostic use, or— quantitative nucleic acid-based in vitro diagnostic examination procedures.
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