GB/T 42080.1-2022 Active National standards

GB/T 42080.1-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1:Isolated RNA

GB/T 42080.1-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1:Isolated RNA

Publish Date: 2022-12-30 Implement Date: 2023-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 42080.1-2022
Standard Type: National standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: -
Publish Date: 2022-12-30
Implement Date: 2023-07-01
Pages: 21 pages

Scope

This document provides guidelines for the processing, recording, storage, and retrieval of frozen tissue samples used for RNA testing during the pre-analysis phase prior to molecular analysis. This document is applicable to any molecular in vitro diagnostic tests conducted in medical laboratories and molecular pathology laboratories on RNA extracted from frozen tissues. It is also applicable to laboratory clients, in vitro diagnostic developers and manufacturers, biobanks, institutions and commercial organizations conducting biomedical research, and regulatory authorities. This document does not include 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 in this document.

Development Information

Word Count: 43 Thousand words Pages: 21 pages

Same series standard

Referenced Standards

Adopt standards

ISO 20184-1:2018

Related Standards

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