Update of the European standards for inactive surgical implants in the area of heart valve prostheses
Update of the European standards for inactive surgical implants in the area of heart valve prostheses
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DOI：
10.1016/j.ejcts.2007.08.015
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发表时间：
2007-11-01
影响因子：
3.4
通讯作者：
Lange, Ruediger
中科院分区：
文献类型：
--
作者：
Eichinger, Walter;Daebritz, Sabine;Lange, Ruediger
目的：心脏瓣膜在欧洲市场的批准是按照欧洲和国际标准进行的。新版EN标准于2006年6月发布，它对心脏瓣膜技术领域的不同技术创新做出了回应。这项工作概述了新的EN ISO 5840（2005）和旧的EN 12006-1（1999）之间的区别。方法：我们比较了“新的”EN ISO 5840（2005）和“旧的”EN 12006-1（1999）。结果:新的EN ISO 5840更新了以下方面：根据患者环的生物和机械心脏瓣膜假体的尺寸指定；环植入位置的区分(环内、环内、环上、心脏瓣膜假体部件描述表无支架假体水动力试验顺应室的使用确定水动力试验中心脏瓣膜假体的最低要求和临床研究中与假体相关的并发症的参考值规范临床长期研究要求的定义(患者数量，引入机械心脏瓣膜5年和生物心脏瓣膜10年的强制性观察时间框架。结论：新EN ISO 5840的更新考虑了心脏瓣膜开发的技术演变。新标准中的一些变化将提高患者的安全性，并确保心脏瓣膜技术领域的高质量。(C) 2007欧洲心胸外科协会。Elsevier B.V.版权所有。
Objective: The approval of a heart valve for the European market takes place in accordance with European and international standards. A new version of the EN Standards was published in June 2006, which responded to different technical innovations in the area of heart valve technology. This work outlines the differences between the new EN ISO 5840 (2005) and the old EN 12006-1 (1999). Methods: We compared the 'new' EN ISO 5840 (2005) and the 'old' EN 12006-1 (1999). Results: The following aspects have been updated in the new EN ISO 5840:Size designation of biological and mechanical heart valve prostheses in accordance with the patient annulusDifferentiation of the annular implantation position (intra-annular, intra-supra-annular, supra-annular) " Table for the description of the components of a heart valve prosthesisUse of compliance chambers for the hydrodynamic testing of prostheses without scaffoldDetermination of the minimum requirement for heart valve prostheses in hydrodynamic tests and specification of reference values with regard to prosthesis - related complications in clinical studiesDefinition of the requirements for clinical long-term studies (patient number, length)Introduction of an obligatory post- observation timeframe of 5 years for mechanical heart valves and of 10 years for biological heart valves.Conclusions: The update in the new EN ISO 5840 gives consideration to the technologic evolution of heart valve development. Several changes in the new standard will improve safety for the patient and ensure high quality in the field of heart valve technology. (C) 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.