CEN/TS 17811:2022

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA


说明:

  • 此图仅显示与当前标准最近的5级引用;
  • 鼠标放置在图上可以看到标题编号;
  • 此图可以通过鼠标滚轮放大或者缩小;
  • 表示标准的节点,可以拖动;
  • 绿色表示标准:CEN/TS 17811:2022 , 绿色、红色表示本平台存在此标准,您可以下载或者购买,灰色表示平台不存在此标准;
  • 箭头终点方向的标准引用了起点方向的标准。

 

 

非常抱歉,我们暂时无法提供预览,您可以试试: 免费下载 CEN/TS 17811:2022 前三页,或者稍后再访问。

点击下载后,生成下载文件时间比较长,请耐心等待......

 



标准号
CEN/TS 17811:2022
发布
2022年
发布单位
欧洲标准化委员会
 
 
代替标准
prEN ISO 18704
适用范围
This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186-3. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

CEN/TS 17811:2022相似标准





Copyright ©2007-2022 ANTPEDIA, All Rights Reserved
京ICP备07018254号 京公网安备1101085018 电信与信息服务业务经营许可证:京ICP证110310号