GB/T 42080.2-2022
Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part2:Isolated proteins (English Version)
- Standard No.
- GB/T 42080.2-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 42080.2-2022
- Scope
- This document provides guidelines for the handling, documentation, storage and extraction of frozen tissue specimens for protein testing in the pre-test phase prior to molecular analysis. This document is applicable to any molecular in vitro diagnostic test performed by medical laboratories and molecular pathology laboratories on proteins extracted from frozen tissues. This document is also applicable to laboratory customers, in vitro diagnostic developers and manufacturers, biobanks, institutional and commercial organizations conducting biomedical research, and regulatory bodies. Note: International, national or regional regulations or requirements can also apply to specific content covered by this document.
GB/T 42080.2-2022 Referenced Document
- GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1: General requirements
GB/T 42080.2-2022 history
- 2022 GB/T 42080.2-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part2:Isolated proteins
