友情提示:本平台主要功能已迁移至全国标准信息公共服务平台,请访问 http://www.std.gov.cn
收藏本站   设为首页
当前位置:国外标准化动态 > 中欧 > 正文

CEN发布关于分子体外诊断检测新系列标准:EN ISO 20166:2018

发布时间: 2019-03-13 14:32:04   审校:睿智  

 

欧洲标准一直致力于提高医疗设备的安全,质量和性能要求,在为患者提供安全的医疗保健服务方面发挥着重要作用。在这种背景下,确保医疗保健和预防的高水平的一个重要内容就是确保患者能得到及时、正确的诊断。
为了最大限度地降低主观臆断的风险,提高诊断安全性,欧洲标准化委员会(CEN)最近发布了一系列标准EN 20166:2018分子体外诊断检测-关于福尔马林固定和石蜡包埋(FFPE)组织预检阶段的规范要求。该标准分为分离RNA、分离蛋白和分离DNA三个部分,涵盖样品采集、记录、存储、处理和多物质分离等分析准备过程。
20166系列标准,主要针对分子体外诊断检测,包括医学实验室和分子病理学实验室开展的检测等等。这些标准同样适用于其它利益相关方,如体外诊断开发商和制造商、生物银行、生物医学研究机构及相关监管机构等。
该标准的目的是致力于减少外部因素对检查结果的影响,确保患者得到尽可能客观的诊断。有明确的科学证据表明,预检阶段中可能存在几个影响原位检测结果的因素,这会对诊断结果造成重大影响。在预检阶段,实验人员对生物样本的处理会对分析结果的可靠性产生显著影响,因此需要制定高水平的关于预检阶段程序的标准。
EN ISO 20166:2018系列标准是基于SPIDIA项目制定的,该项目是由欧盟提供资助的一个为期4年半的项目。项目的合作伙伴、制造商、欧洲和国际研究组织、用户和研究人员都参与了规范的制定。其后续的项目是一个为期48个月的SPIDIA4P项目(个性化药物体外诊断通用前分析程序的标准化项目)项目,目前正致力于体外诊断分析前流程的标准化和流程改善工作。
这一系列标准是由CEN / TC 140‘体外诊断医疗设备’委员会制定,与ISO / TC 212‘临床实验室测试和体外诊断测试系统’技术委员会密切相关。CEN / TC 140的秘书处工作是由德国国家标准化协会(DIN)承担。DIN也是SPIDIA和SPIDIA4P项目的合作伙伴之一。想获悉更多的国内外标准信息,请访问中国标准信息服务网(<https://www.sacinfo.cn>)。
 

New CEN standard: Better diagnoses, thanks to EN ISO 20166:2018 series ‘Molecular in vitro diagnostic examinations’

European Standards have a fundamental role in providing safe access to healthcare for patients by setting safety, quality and performance requirements for medical devices. In this context, an important part of ensuring high levels of healthcare and prevention derives from making sure that diagnoses are correct and timely.

To minimise the risk of non-objective diagnoses and increase safety, CEN recently published the series of standards EN 20166:2018 ‘Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue’. Within its three parts on isolated RNA, isolated proteins and isolated DNA, this series covers the processes of analysis preparation, starting from sample collection to handling, documentation, storage and processing of specimens to the isolation of various substances.

The standards included in the 20166 series are specifically designed for molecular in vitro diagnostic examinations, including laboratory tests, performed by medical laboratories and molecular pathology laboratories. They are also applicable to other stakeholders, such as in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial performing biomedical research and regulatory authorities.

The objective of this standard series is to reduce the impact of external factors on the results of examinations, thus ensuring that patients obtain diagnoses that are as objective as possible. Indeed, in research there is clear scientific evidence that several factors of the pre-examination phase influence the outcome of in situ detection and, thus, can have major impact on the diagnostic results. Since the reliability of analytical results in examinations is markedly dependent on the proper processing of the biospecimen during the pre-examination phase, a high level of standardization of the procedures of the pre-examination phase is required.

The EN ISO series 20166:2018 was developed in the framework of the SPIDIA project, a 4.5-year project funded by the European Union. Project partners, as well as representatives from a wider community of manufacturers, European and international research associations, users and researchers provided input on the content of the specifications. Its successor, the 48-month-project SPIDIA4P (Standardization of generic Pre-analytical Procedures for In vitro DIAgnostics for Personalised Medicine), is taking up the work on standardization and improvement of pre-analytical procedures for in vitro diagnostics.

The standard series was developed  by CEN/TC 140 ‘In vitro diagnostic medical devices’, in close contact with ISO/TC 212 ‘Clinical laboratory testing and in vitro diagnostic test systems’. The Secretariat of CEN/TC 140 is held by DIN, Germany’s National Standardization Body, who is one of the partners of the SPIDIA and SPIDIA4P projects.


来源: CEN 官网
京ICP备09001239号
网站管理:国家标准化管理委员会标准信息中心
地址:北京海淀区马甸东路9号 邮编:100088 邮箱:info@sac.gov.cn
客服热线:010-82261056 QQ号:3433774297
  • 版权所有 侵权必究
  • 主管:国家标准化管理委员会
  • 主办:国家标准化管理委员会标准信息中心
  • 运营:北京中标赛宇科技有限公司
  • 经营许可证编号 京ICP证 号
  • 盗版侵权 举报热线:400-650-6190
  • 关于我们
  • 技术团队
  • 合作伙伴
  • 法律声明
  • 知识产权