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首页> 外文期刊>Journal of Stem Cells and Regenerative Medicine >Setting standards: European and international standardization landscape in the field of medical devices utilizing tissues
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Setting standards: European and international standardization landscape in the field of medical devices utilizing tissues

机译：制定标准：利用纸巾的医疗设备领域的欧洲和国际标准化前景

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Standards generate economic benefits which have been estimated at 16 billion euros a year for Germany alone. They facilitate trade, spread knowledge, disseminate innovative advances in technology, and share good management and conformity assessment practices. The poster provides an overview on the portfolio of European and International Standards available from the work of Technical Committee CEN/TC 316 .Medical devices utilizing tissues" of the European Standardization Organization (CEN) and its sister Technical Committees, ISO/TC 194/SC 1 .Biological evaluation of medicaldevices"/.Tissue product safety" and ISO/TC 150/SC 7 .Surgical implants"/.Tissue engineered medical products" of the International Organization for Standardization (ISO). Standardization provides excellent opportunities for shaping the business environment of current and future markets for tissue engineered medical devices and advanced therapy medicinal products both on the European scale and worldwide. Current projects and potential areas of future activities of the relevant CEN and ISO Technical Committees will be outlined and information given on how to get involved, be it by joining in current activities or by submitting proposals for new projects.The standardization toolkit comprises a variety of publication types. The range of publication types available within the European and International Standardization systems with their particularities will be described and an introduction to the mechanisms of consensus-based standardization given. Standardization is a strategic instrument for economic success. Learn more about how standards are made and how to get involved in CEN/TC 316 and/or its international counterparts to gain a competitive lead through timely access to information and knowledge. Join in to prepare the grounds which form an integral part of the business environment for the market success of your innovative products for application in regenerative medicine. For interested parties based in Germany, the German Standards Institute DIN Deutsches Institut f¨1r Normunge. V. can offer financial support for participation in standardization activities, within the framework of a BMBF funded project
机译：这些标准产生的经济效益仅在德国每年就估计有160亿欧元。它们促进贸易，传播知识，传播技术上的创新进步，并共享良好的管理和合格评定实践。海报概要介绍了可从CEN / TC 316技术委员会的工作中获得的欧洲和国际标准组合。“欧洲卫生组织（CEN）及其姐妹技术委员会ISO / TC 194 / SC”的“利用组织的医疗器械” 1。对医疗器械的“ /。组织产品安全性”和ISO / TC 150 / SC进行生物学评估7.国际标准化组织（ISO）的“外科植入物//组织工程医学产品”。标准化为塑造业务提供了极好的机会欧洲和全球范围内组织工程医疗设备和先进治疗药物的当前和未来市场环境，将概述相关CEN和ISO技术委员会的当前项目和未来活动的潜在领域，并提供有关如何获得的信息通过参与当前活动或为新项目提交提案来参与。工具包包含多种出版物类型。将描述欧洲和国际标准化体系内可用的出版物类型的范围及其特殊性，并介绍基于共识的标准化机制。标准化是实现经济成功的战略工具。了解有关如何制定标准以及如何参与CEN / TC 316和/或其国际同行的更多信息，以通过及时获取信息和知识获得竞争优势。齐心协力，为在再生医学中应用的创新产品在市场上取得成功奠定基础，这是商业环境必不可少的组成部分。对于总部设在德国的有关方面，德国标准协会DIN Deutsches Institutfâ1rNormunge。 V.可以在BMBF资助的项目框架内为参与标准化活动提供财务支持

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