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 (English Version)
- Standard No.
- GB/T 39367.1-2020
- Language
- Chinese, Available in English version
- Release Date
- 2020
- Published By
- 国家市场监督管理总局、中国国家标准化管理委员会
- Latest
- GB/T 39367.1-2020
- Scope
- This part of GB/T 39367 is applicable to: — manufacturers of in vitro diagnostic medical devices, medical laboratories and scientific research laboratories developing nucleic acid-based qualitative in vitro diagnostic test procedures for the detection and identification of microbial pathogens in human specimens; and — - medical laboratories that perform nucleic acid-based in vitro diagnostic tests for the detection and identification of microbial pathogens in human specimens. This section does not apply to: --- Nucleic acid tests whose intended use is not in vitro diagnostics; or --- Nucleic acid-based quantitative in vitro diagnostic test procedures.
GB/T 39367.1-2020 Referenced Document
- 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
GB/T 39367.1-2020 history
- 2020 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
