标准编号：ISO 20166-3:2018
中文名称：分子体外诊断检验 福尔马林固定和石蜡包埋组织预检验过程规范 第3部分：分离DNA
英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
发布日期：2018-12
标准范围
This document gives guidelines on the handling, documentation, storage and processing of formalin-
fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA 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.
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