GB/T 39367.1-2020 Replaced National standards

GB/T 39367.1-2020 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 definitions

GB/T 39367.1-2020 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 definitions

Publish Date: 2020-11-19 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 39367.1-2020

Standard Type: National standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical devices

ICS Name: Experiment (vocabulary)

Publish Date: 2020-11-19

Implement Date: 2022-06-01

Publisher: 国家市场监督管理总局、国家标准化管理委员会

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: 24 pages

Scope

GB/T 39367的本部分适用于：
——为检测和鉴定人类标本中的微生物病原体而开发基于核酸的定性体外诊断检验程序的体外诊断医疗器械制造商、医学实验室和科研实验室；以及
——为检测和鉴定人类标本中的微生物病原体而进行基于核酸的体外诊断检验的医学实验室。
本部分不适用于:
——预期用途不是体外诊断的核酸检验；或
——基于核酸的定量体外诊断检验程序。

Development Information

Drafting Units:

北京市医疗器械检验所、中国合格评定国家认可中心、深圳华大因源医药科技有限公司、中山大学达安基因股份有限公司

Drafting Persons:

代蕾颖、付岳、宫艳萍、蒋析文、王瑞霞

Word Count: 37 Thousand words Pages: 24 pages

Superseded by the following standards

GB/T 39367-2025 In vitro diagnostic test systems—Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens—Laboratory quality practice guide

Referenced Standards

GB 19781-2005 Medical laboratories—Requirements for safety GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1:General requirements GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents ISO 13485:2003 BIPM JCGM 200:2012

Adopt standards

ISO/TS 17822-1:2014

Related Standards

GB/T 12604.7-1995 Replaced

GB/T 12604.7-1995 Terminology for nondestructive testing—Leak testing

Publish Date: 1995-12-20

GB/T 12604.8-1995 Replaced

GB/T 12604.8-1995 Terminology for nondestructive testing—Neutron testing

Publish Date: 1995-12-20

GB/T 12604.3-2005 Replaced

GB/T 12604.3-2005 Non-destructive testing—Terminology—Terms used in penetrant testing

Publish Date: 2005-06-08

GB/T 12604.4-2005 Active

GB/T 12604.4-2005 Non-destructive testing—Terminology—Terms used in acoustic emisson testing

Publish Date: 2005-06-08

GB/T 12604.2-2005 Active

GB/T 12604.2-2005 Non-destructive testing—Terminology—Terms used in radiographic testing

Publish Date: 2005-09-19

GB/T 20737-2006 Active

GB/T 20737-2006 Non-destructive testing—General terms and definitions

Publish Date: 2006-12-25