ISO 20166-1-2018 分子体外诊断检验--福尔马林固定和石蜡包埋(FFPE)组织预检验过程规范--第1部分:分离RNA Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA

This document gives guidelines on the handling, documentation, storage and processing of formalin- fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre- examination phase before a molecular assay is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.