GB/T 42216.1-2022
Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 1:Isolated RNA (English Version)

Standard No.

GB/T 42216.1-2022

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 42216.1-2022

Scope

This document provides guidelines for the handling, documentation, storage, and extraction of formalin-fixed and paraffin-embedded tissue (FFPE) specimens for RNA testing in the pre-test phase prior to molecular analysis. This document applies to molecular in vitro diagnostic tests, including laboratory self-built testing items carried out by medical laboratories and molecular pathology laboratories, and also applies to laboratory customers, in vitro diagnostic developers and manufacturers, biological sample banks, and biomedical Research institutions and business organizations as well as regulators. Note: International, national and regional regulatory requirements also apply to specific content covered in this document.

GB/T 42216.1-2022 Referenced Document

• GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1: General requirements
• GB/T 27020-2016 Conformityassessment.Requirements for the operation of various types of bodies performing inspection
• ISO 15189 Medical laboratories - Requirements for quality and competence [Standard in Spanish]
• ISO 15190 Medical laboratories — Requirements for safety

GB/T 42216.1-2022 history

• 2022 GB/T 42216.1-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 1:Isolated RNA

GB/T 42216.1-2022 -All Parts