GB/T 42216.2-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue—Part 2:Isolated proteins (English Version)
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
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GB/T 42216.2-2022
Scope
This document provides guidelines for the handling, documentation, storage, and extraction of formalin-fixed and paraffin-embedded tissue (FFPE) specimens for protein testing in the pre-test phase prior to molecular analysis. This document applies to molecular in vitro diagnostic tests, including laboratory self-built test items carried out by medical laboratories and molecular pathology laboratories, and also applies to laboratory customers, in vitro diagnostic developers and manufacturers, biobanks, and those engaged in biomedical research institutions and business organizations and regulators. This document does not apply to protein detection based on immunohistochemical techniques. Note: International, national and regional regulatory requirements also apply to specific content covered in this document.
GB/T 42216.2-2022 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 42216.2-2022 history
2022GB/T 42216.2-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue—Part 2:Isolated proteins