Medical Device医疗器械相关文本译文.doc

Medical DeviceA 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。DefinitionsEuropean Union legal framework and definitionBased 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 devicesThey 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/EEC医疗器械，关于体外诊断医疗器械指令98/79/EC他们的目标是在确保高水平的保护人类健康和安全和单一，市场的良好运作。随着时间的推移，一些修改和执行指令，这些指令有3 个主要的补充，包括最后的技术性修订，2007年由指令带来的/47/EC。Directive 2007/47/EC defines a medical device as:“any instrument ,apparatus,Appliance ,software ,material or other article ,whether used alone or in combination ,including the software intended by its manufacturer to be used specifically for diagnostic and or therapeutic purposes and necessary for its proper application ,intended by the manufacturer to be used for human beings.Devices are to be used for the purpose of:指令2007/47/EC定义为医疗器械：“任何仪器，设备，家电，软件，材料或者其它物品，无论是单独使用或组合，包括通过其制造商的软件，以专门用于诊断或治疗的目的和正确应用所必需的由拟制造商必须为人类使用。设备将用于为宗旨：Diagnosis ,prevention ,monitoring ,treatment or alleviation of disease.Diagnosis ,monitoring ,treatment ,alleviation of or compensation for an injury or handicap.Investigation ,replacement or modification of the anatomy or of a physiological processControl of conceptionThis includes devices that do not achieve its principal Intended action in or on the human body by pharmacological immunological or metabolic means ,but Which may be assisted in its function by such means.” In UK the Medicines and Healthcare Products Regulatory Agency (MHRA) acts as a CA，in Italy it is the Ministers Salute (Ministry of Health). Medical devices must not be mistaken with medicinal products. In the EU，all medical devices must be identified with the CE mark. List of Medical Devices诊断，预防，监测，治疗或减轻疾病。诊断，监测，治疗，减轻或损伤或者残疾赔偿。解剖或生理过程的调查，更换或修改控制的概念这包括没有达到其主要的设备拟或对人体的作用药理免疫学或者代谢的手段，但它可协助等手段，在其功能”英国药品和保健产品监管署（MHRA）作为一个CA，它在意大利部长礼炮（卫生部）。医药产品，医疗器械不得误。在欧盟，必须确定所有的医疗器械CE标志。医疗器械名单High-risk devicesHigh-risk devices are life supports ,critical monitoring ,energy emitting and other devices whose failure or misuse is reasonably likely to seriously injure patient or staff . Examples include:Anesthesia unitAnesthesia respiratorApnea monitorsArgon enhanced coagulation unit AspiratorsAuto transfusion unitsCardiac defibrillator (external or internal)Electrosurgical unitsFetal monitorsHeart-lung machineIncubatorsInfusion pumpInvasive blood pressure unitsPulse dosimeter Radiation-therapy machines VentilatorStent 高风险设备高风险设备，生命支持，关键监测，能源排放和其它设备的故障或误用是合理，可能会严重伤害病人或工作人员。例子包括：麻醉单位麻醉呼吸呼吸暂停监视器氩强化混凝单元吸气自动输血单位心脏转复除颤器（内部或外部）电台胎儿监护仪心肺机孵化器创血压单位脉冲剂量放射治疗机通风架支架 Medium-risk devicesThese are devices including many diagnostic instruments whose misuse. Failure or absence (e.g. out of service) with no replacement available would have a significant impact on patient care, but would not be likely to cause direct serious injury .Example include: ECGEEGTreadmillsUltrasound sensorsPhototherapy unitsEndoscopesHuman-implantable RFID chipsSurgical drill and saws Laparoscopic insufflatorsRadiant warmers (adult)Zoophagous agents (e.g. medicinal leeches: medicinal maggots)Lyric bacteriophage 中等风险设备这些包括许多滥用的诊断仪器设备。失败或没有更换的情况下可用（如服务）将有一个对病人护理产生重大影响，但不会有可能造成直接严重伤害，例如包括：心电图脑电图跑步机超声波传感器光疗单位内窥镜人类植入RFID芯片手术钻和锯充气式腹腔镜辐射加热器（成人）食肉代理物（如药用水蛭药用蛆）抒情的噬菌体Low-risk devicesDevices in this category are those whose failure or misuse is unlikely to result in serious consequences.Examples:Electronic thermometer Breast pumpsSurgical microscopeUltrasonic nebulizersSphygmomanometersSurgical table Surgical lightsTemperature monitorAspiratorsX-ray diagnostic equipmentLensometerKeratometer低风险设备在这一类的设备的故障或误用是不太可能导致严重后果。例子：电子体温计吸奶器手术显微镜超声波雾化器血压计手术台手术灯温度监视器吸气机X射线诊断设备焦度计角膜Standardization and Regulatory Concerns The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01.The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. Further standards are IEC 60601-1, for electrical devices (mains-powered as well as battery powered) and IEC 63204 for medical software. The US FDA also published a series of guidances for industry regarding this topic against 21 CFR Subchapter H-Medical Devices. Starting in the late 1980s the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device (Therac-25) that overdosed patients because of software coding errors. FDA is now focused on regulatory oversight on device software development process and system-level testing.标准化和监督问题医疗设备的ISO标准涵盖由ICS11.100.20和召开11.040.01.质量和风险管理方面的主题为监管目的的是通过ISO13485和ISO14971。进一步的标准是IEC63204.美国FDA还公布了一系列关于这个主题，对21病死率节关于H-医疗器械行业指导的。在20世纪80年代末开始了FDA增加其在检讨医疗设备软件开发的参与。沉淀的变化是放射治疗设备，过量是病人，因为软件编码错误（医用直线加速器-25）。FDA目前集中在设备软件开发过程和系统级测试的监管。Packaging Standards Medical device packaging is highly