GB/T 44467-2024
ActiveMolecular in vitro diagnostic examinations—Specifications for pre-examination processes for saliva—Isolated human DNA
分子体外诊断检验 唾液检验前过程的规范 提取人类DNA
Application Summary AI generated
This standard specifies the requirements for the pre-examination phase of molecular in vitro diagnostic testing using saliva samples, covering collection, transport, storage, and processing to ensure the quality of isolated human DNA. It is applied in clinical laboratories and healthcare settings where saliva is used as a non-invasive specimen for genetic testing, disease screening, or pharmacogenomics. The standard ensures consistency and reliability in DNA extraction before downstream molecular analysis.
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 43280-2023
Medical laboratories—Practical guidance for the estimation of measurement uncertainty
GB/Z 43281-2023
Guidance for supervisors and operators of point-of-care testing(POCT) devices
GB/Z 44363-2024
Pyrogenicity—Principles and methods for pyrogen testing of medical devices
GB/Z 157-2026
In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
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.