标准编号：ISO 20184-1:2018
中文名称：分子体外诊断检验 冷冻组织预检验过程规范 第1部分：分离RNA
英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
发布日期：2018-11
标准范围
This document gives guidelines on the handling, documentation, storage and processing of frozen
tissue specimens intended for RNA examination during the pre-examination phase before a molecular
assay is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical
laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is
also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers,
biobanks, institutions and commercial organisations performing biomedical research, and regulatory
authorities.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in
this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics
covered in this document.
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