GB/T 42080.3-2024

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 3: Isolated DNA

分子体外诊断检验 冷冻组织检验前过程的规范 第3部分:分离DNA

Standard Type
GBT
ICS
11.100.10
CCS
C30
Status
Active
Issue Date
2024-09-29
Implementation
2025-04-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the requirements for the handling, documentation, and processing of frozen tissue specimens prior to DNA extraction for molecular in vitro diagnostic testing. It is applied in clinical laboratories and pathology settings to ensure the quality and integrity of isolated DNA used in downstream genetic analyses, such as PCR or sequencing, for disease diagnosis and research. The standard is relevant for healthcare professionals and manufacturers involved in pre-analytical workflows for frozen tissue samples.

Related Standards

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.