MedicalDevice医疗器械相关文本译文.docVIP

Medical Device A medical device is a product which is used for medical purposes in patients ,in diagnosis ,therapy or surgery .Whereas medical products(also called pharmaceuticals)achieve their principal action by pharmacological ,metabolic or immunological means .Medical devices are include in the category :Medical technology .Examples included tongue dangerous medical thermometers ,blood sugar meters ,total artificial hearts ,fibrin scaffolds ,stents and X-ray machines .The global market of medical devices reached roughly 209 billion US Dollar in 2006 and is expected to grow with an average annual rate of 6-9% through 2010. 医疗器械 医疗器械是一个用于医疗目的的患者，在诊断，治疗或手术，而医疗产品（也称为药品），药理，代谢或免疫手段实现其主要的行动医疗器械包括类别产品。医疗技术。包括舌头的危险医疗温度计，血糖米，总的人工心脏，纤维蛋白支架，支架和X光机。全球医疗器械市场在2006年达到大约209亿美元，预计平均增长到2010年的6-9%的年增长率。 Definitions European Union legal framework and definition Based on the “New Approach ”,rules relating to the safety and performance of medical devices were harmonized in the EU in the 1990s.The “New Approach” ,defined in a European Council Resolution of May 1985,represents an innovative way of technical harmonization .it aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators allowing for the free movement of goods inside the EU .The core legal framework consists of 3 directives: Directive 90/385/EEC ,regarding active implantable medical devices; Directive 93/42/EEC regarding medical devices; Directive 98/79/EC regarding in vitro diagnostic medical devices They aim at ensuring a high level of protection or human health and safety and the good functioning of the Single ,Market .These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC. 定义 欧洲联盟的法律框架和定义 基于“新方法”，医疗器械的安全性和性能有关的规则1990s.这个“新方法”的定义在欧洲议会的决议一九八五年五月在欧盟统一的，统一的技术创新方式它旨在消除技术性贸易壁垒，并允许在欧盟内部货物的自由流动的经济运营商消除由此产生的不确定性。核心的法律框架由3指令。 指令90/385/EEC，就主动植入式医疗设备， 指令90/42