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
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 Medical laboratories.Particular requirements for quality and competence
GB/T 39367.1-2020 history
2020GB/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