CEN/TS 17305-2019

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA


CEN/TS 17305-2019 发布历史

This document gives requirements on the handling@ storage@ processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. 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. Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this technical specification. Neither are measures for preserving and handling of native saliva cell-free DNA@ pathogens@ and other bacterial or whole microbiome DNA in saliva described. NOTE International@ national or regional regulations or requirements can also apply to specific topics covered in this document.

CEN/TS 17305-2019由CEN - European Committee for Standardization 发布于 2019-04-01,并于 2019-04-17 实施。

CEN/TS 17305-2019的历代版本如下:

 

 

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 17305-2019 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 17305-2019
发布日期
2019年04月01日
实施日期
2019年04月17日
废止日期
中国标准分类号
/
国际标准分类号
/
发布单位
CEN - European Committee for Standardization
引用标准
20
适用范围
This document gives requirements on the handling@ storage@ processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. 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. Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this technical specification. Neither are measures for preserving and handling of native saliva cell-free DNA@ pathogens@ and other bacterial or whole microbiome DNA in saliva described. NOTE International@ national or regional regulations or requirements can also apply to specific topics covered in this document.




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