CEN/TS 16835-1-2015
分子体外诊断检查.静脉全血预审流程的规范.第1部分:核糖核酸细胞的分离

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA

CEN/TS 16835-1-2015 发布历史

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage. Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification. RNA in pathogens present in blood is not covered by this Technical Specification.

CEN/TS 16835-1-2015由欧洲标准化委员会 IX-CEN 发布于 2015-07-01。

CEN/TS 16835-1-2015 在中国标准分类中归属于: C38 普通诊察器械。

CEN/TS 16835-1-2015 发布之时，引用了标准

• EN ISO 15189-2012 医学实验室.质量和资格的要求*， 2022-07-29 更新
• EN ISO 22174-2005 食物和动物饲料的微生物学.食物病原体检测用聚合酶链式反应(PCR ).一般要求和定义 ISO 22174-2005
• ISO Guide 30-1992 与标准物质有关的术语和定义
• ISO 15190-2003 医学实验室.安全要求

* 在 CEN/TS 16835-1-2015 发布之后有更新，请注意新发布标准的变化。

CEN/TS 16835-1-2015的历代版本如下：

• 2015年07月01日 CEN/TS 16835-1-2015 分子体外诊断检查.静脉全血预审流程的规范.第1部分:核糖核酸细胞的分离

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标准号

CEN/TS 16835-1-2015

发布日期

2015年07月01日

实施日期

废止日期

无

中国标准分类号

C38

国际标准分类号

11.100.10

发布单位

IX-CEN

引用标准

EN ISO 15189-2012 EN ISO 22174-2005 ISO Guide 30-1992 ISO 15190-2003

被代替标准

FprCEN/TS 16835-1-2015

适用范围

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage. Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification. RNA in pathogens present in blood is not covered by this Technical Specification.