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现行 EN ISO 20186-1:2019
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019) 分子体外诊断检查 - 静脉全血预检过程规范 - 第1部分:分离的细胞RNA(ISO/DIS 20186-1:2016)
发布日期: 2019-03-27
实施日期: 2019-03-27
本国际标准建议在进行分子测定之前,在预检阶段期间处理,记录,储存和处理旨在用于细胞RNA检查的静脉全血标本。本国际标准涵盖静脉采血管采集的标本。本国际标准适用于分子体外诊断检查,包括医学实验室进行的实验室开发测试。它还旨在由实验室客户,体外诊断开发人员和制造商使用,也适用于执行生物医学研究,生物银行和监管机构的机构和商业组织。 采血后血细胞RNA谱可能发生显着变化。因此,需要采取特殊措施,确保优质的血液样品进行细胞RNA检查和储存。 需要采取不同的专门措施来稳定血液中循环血液中的无血液循环RNA和RNA,这在本国际标准中没有描述。 收集,稳定,运输和储存毛细血液以及通过纸基技术收集和储存血液需要采取不同的专门措施
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical 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. Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom. RNA in pathogens present in blood is not covered by this document.
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归口单位: CEN/TC 140-
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