GB/T 42216.4-2024 Active National standards

GB/T 42216.4-2024 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue—Part 4:In situ detection technique

Publish Date: 2024-08-23 Implement Date: 2025-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 42216.4-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2024-08-23

Implement Date: 2025-03-01

Pages: 32 pages

Scope

This document provides guidelines for the processing, recording, storage, and retrieval of formalin-fixed and paraffin-embedded (FFPE) tissue samples for in situ detection prior to molecular analysis. This document is applicable to molecular in vitro diagnostic tests, including laboratory-developed testing projects conducted in medical laboratories and molecular pathology laboratories; it is also applicable to laboratory clients, in vitro diagnostic developers and manufacturers, biobanks, institutions engaged in biomedical research, and commercial organizations, as well as regulatory authorities. This document is not applicable to the pre-analysis phase of isolating RNA, proteins, and DNA from FFPE tissues. Note: International, national, and regional regulations also apply to the specific content covered in this document.