GB/T 42080.3-2024 Active National standards

GB/T 42080.3-2024 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 3:Isolated 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 42080.3-2024

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: 20 pages

Scope

This document specifies the requirements for the handling, recording, storage, and retrieval of frozen tissue samples used for DNA testing during the pre-analysis phase prior to molecular analysis, and provides corresponding recommendations. This document is applicable to molecular in vitro diagnostic tests conducted in medical laboratories and molecular pathology laboratories on DNA extracted from frozen tissues, including laboratory-developed tests. It is also applicable to laboratory clients, in vitro diagnostic developers and manufacturers, biobanks, institutions conducting biomedical research, commercial organizations, and regulatory authorities. This document does not apply to tissues that have undergone chemical stabilization pretreatment before freezing. Note: International, national, or regional regulations or requirements may also apply to the specific content covered by this document.