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

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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

Pages: 24 pages

Scope

This part of GB/T 39367 is applicable to:
—— Manufacturers of in vitro diagnostic medical devices, medical laboratories, and scientific research laboratories that develop nucleic acid-based qualitative in vitro diagnostic testing procedures for detecting and identifying microbial pathogens in human specimens; and
—— Medical laboratories that conduct nucleic acid-based in vitro diagnostic testing for detecting and identifying microbial pathogens in human specimens.
This part is not applicable to:
—— Nucleic acid tests that are not intended for in vitro diagnosis; or
—— Nucleic acid-based quantitative in vitro diagnostic testing procedures.

Development Information

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Superseded by the following standards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