GB/T 44467-2024 Active National standards

GB/T 44467-2024 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for saliva—Isolated human DNA

Publish Date: 2024-09-29 Implement Date: 2025-04-01 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 44467-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2024-09-29

Implement Date: 2025-04-01

Pages: 15 pages

Scope

This document specifies the requirements for handling, storing, disposing of, and recording saliva samples intended for human DNA testing during the pre-test phase of molecular testing, and provides corresponding recommendations.
This document applies to molecular in vitro diagnostic testing, including laboratory-built projects conducted in medical laboratories and molecular pathology laboratories; it also applies to laboratory clients, in vitro diagnostic developers and manufacturers, biobanks, institutions and commercial organizations engaged in biomedical research, and regulatory authorities.
This document does not include special measures required for collecting saliva on absorbent materials or by rinsing the mouth, as well as measures for preserving and processing free DNA, pathogens, and other bacteria or the entire microbiome DNA in saliva.