GB/T 39367-2025
ActiveIn vitro diagnostic test systems—Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens—Laboratory quality practice guide
体外诊断检测系统 基于核酸扩增的病原微生物检测和鉴定程序 实验室质量实践通则
Application Summary AI generated
This standard provides a quality practice guide for laboratories performing nucleic acid amplification-based tests to detect and identify microbial pathogens. It is applied in clinical and diagnostic laboratory settings to ensure the reliability, accuracy, and reproducibility of in vitro diagnostic procedures, such as PCR testing for infectious diseases. The standard covers pre-analytical, analytical, and post-analytical processes, including sample handling, reagent quality, and result interpretation.
Related Standards
GB/T 19634-2005
In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing
GB/T 47486-2026
General technical requirements for vasculature-on-a-chip
GB/Z 30154-2013
Medical laboratories―Guidance on laboratory implementation of GB/T 22576-2008
GB/Z 16886.22-2022
Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/Z 43281-2023
Guidance for supervisors and operators of point-of-care testing(POCT) devices
GB/Z 43280-2023
Medical laboratories—Practical guidance for the estimation of measurement uncertainty
GB/Z 44363-2024
Pyrogenicity—Principles and methods for pyrogen testing of medical devices
GB/Z 136-2026
Medical laboratories—Reagents for staining biological specimen—Guidance for users
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.