EN ISO 20186-3:2019
分子体外诊断检查 - 血液预检过程规范 - 细胞RNA - 第3部分:血浆中分离的循环无细胞DNA

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

作废

EN ISO 20186-3:2019 发布历史

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test 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 genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.

EN ISO 20186-3:2019由欧洲标准化委员会 IX-CEN 发布于 2019-10-23，并于 2020-01-31 实施，于 2022-10-31 废止。

。

EN ISO 20186-3:2019的历代版本如下：

• 2019年 EN ISO 20186-3:2019 分子体外诊断检查 - 血液预检过程规范 - 细胞RNA - 第3部分:血浆中分离的循环无细胞DNA

非常抱歉，我们暂时无法提供预览，您可以试试： 免费下载 EN ISO 20186-3:2019 前三页，或者稍后再访问。

注意： 点击下载后，生成下载文件时间比较长，请耐心等待......

标准号

EN ISO 20186-3:2019

发布

2019年

发布单位

欧洲标准化委员会

当前最新

EN ISO 20186-3:2019

 

 

被代替标准

CEN/TS 16835-3:2015

适用范围

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test 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 genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.

EN ISO 20186-3:2019相似标准

推荐

EN ISO 20186-3:2019 中可能用到的仪器设备