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：

• 2019年04月01日 CEN/TS 17305-2019

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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

无

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.