MDD_Classification_Chart.doc

Classification decision chart MDD Art. 9,ANNEX IX III. ClassificationPerformer:执行者Company: 公司Date: 时间Product产品Name名字 Model/Article nr型号/物品编码Version版本Intended use预期用途 Duration持续性 Temporary 暂时性 Short 简短 Prolonged 持久性Invasive侵略性 Non-invasive 非侵略性 Invasive有侵略性 Surgical invasive外科侵入 Reusable surgical instruments可重复使用的手术器械 Implants机械植入器Active 活跃性 Non-Active 稳定的 Active 活跃 Active therapeutic 积极治疗 Active diagnostic 主动诊断CE-class and rule CE 等级和规则1 Classification 等级Rule规则A/NADescription Non-invasive devices非侵略性设备1.1 Rule 1All non-invasive devices are in Class I, unless oneof the rules set out hereinafter applies 所有非侵入性设备在I类，除非下文列出的适用规则之一1.2 Rule 2All non-invasive devices intended for channelingor storing blood, body liquids or tissues, liquids orgases for the purpose of eventual infusion,administration or introduction into the body are inClass IIa: if they may be connected to an active medicaldevice in Class IIa or a higher class, if they are intended for use for storing orchanneling blood or other body liquids or forstoring organs, parts of organs or body tissues, inall other cases they are in Class I.用于引导或储存血液，体液或组织，液体或气体为最终输液，给药或引进的目的，进入人体的所有非侵入性器械属于IIa类：如果它们可以被连接到在IIa类的活跃医疗装置或更高类如果他们打算用于储存或引导血液或其他体液或储存器官或人体组织的一部分，在其他情况下，它们属于I类。1.3 Rule 3All non-invasive devices intended for modifying thebiological or chemical composition of blood, otherbody liquids or other liquids intended for infusion intothe body are in Class IIb, unless the treatment consistsof filtration, centrifugation or exchanges of gas, heat,in which case they are in Class IIa.用于修改血液中的生物或化学组合，用于输注到体内其它体液或其他液体的所有非侵略性器械是在IIb类中，除非处理包括过滤，离心或气体的交流，高温，在这种情况下，它们是在IIa类的1.4 Rule 4All non-invasive devices which come into contactwith injured skin: are in Class I if they are intended to be used as amechanical barrier, for compression or for absorption of exudates, are in Class IIb if they are intended to be usedprincipally with wounds which have breached the dermis and can only heal by secondary intent, are in Class IIa in all other cases, including devices principally intended to manage the micro environment of a wound.所有接触到受伤皮肤的非侵入性的设备：如果它们被用作机械屏障，用于压缩或排泄物的吸收属于I类，如果他们的目的是用它破坏了真皮，让伤口逐渐自行愈合，不缝合的情况属于IIb类在所有其他情况下，包括主要用于管理伤口的微环境中的设备，都属于IIa类Invasive devices侵略性设备2.1. Rule 5All invasive devices with respect to body orifices,other than surgically invasive devices and whichare not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I: are in Class I if they are intended for transientuse, are in Class IIa if they are intended forshort-term use, except if they are used in the oralcavity as far as the pharynx, in an ear canal up tothe ear drum or in a nasal cavity, in which casethey are in Class I, are in Class IIb if they are intended forlong-term use, except if they are used in the oralcavity as far as the pharynx, in an ear canal up tothe ear drum or in a nasal cavity and are notliable to be absorbed by the mucous membrane,in which case they are in Class IIa.All invasive devices with respect to body orifices,other than surgically invasive devices, intended forconnection to an active medical device in Class IIaor a higher class, are in Class IIa.相对于体窍的所有侵入性装置，比如其他手术微创设备和不用于连接到活性医疗器械或是用于连接到活性医疗器械属于I类：如果他们用于短暂性使用，属于I类如果他们用于短期使用的属于IIa类，除非他们是用在口腔咽喉中，在耳道耳朵上鼓或在鼻腔内，在这种情况下，他们属于I类如果他们是为长期使用的属于IIb类，除非他们是用在口腔咽喉中，在耳道耳朵上鼓或在鼻腔内，不易被粘膜吸收，在这种情况下，他们在IIa。相对于体窍所有侵入性装置，比其他手术侵入性装置，用于连接在IIa或更高级别的活性医疗器械，属于IIa类。2.2 Rule 6All surgically invasive devices intended fortransient use are in Class IIa unless they are: intended specifically to control, diagnose,monitor or correct a defect of the heart or of thecentral circulatory system through direct contactwith these parts of the body, in which case theyare in Class III, reusable surgical instruments, in which case theyare in Class I, intended specifically for use in direct contactwith the central nervous system, in which casethey are in Class III, intended to supply energy in the form ofionising radiation in which case they are in ClassIIb, intended to have a biological effect or to bewholly or mainly absorbed in which case they arein Class IIb, intended to administer medicines by means ofa delivery system, if this is done in a manner thatis potentially hazardous taking account of themode of application, in which case they are inClass IIb.针对短暂使用的所有外科侵入性设备属于IIa类，除非它们是：用于在控制，诊断，监测或纠正心脏或中央循环系统的缺陷，通过直接接触身体的这些部分，在这种情况下，他们属于III类可重复使用的外科手术器械，在这种情况下，他们属于I类专门用于与中枢神经系统直接接触的，在这种情况下，他们属于III类用电离辐射的方式提供能量的形式，这种情况下属于IIb类旨在产生生物效应或将全部或大部分被吸收在这种情况下，他们属于IIb类旨在通过一个递送系统的方法来管理药品，如果这是在一个考虑到应用程序到潜在的危险是的模式，在这种情况下，它们是属于IIb类的2.3. Rule 7All surgically invasive devices intended forshort-term use are in Class IIa unless they areintended: either specifically to control, diagnose, monitoror correct a defect of the heart or of the circulatory system through direct contact withthese parts of the body, in which case they are inClass III, or specifically for use in direct contact with thecentral nervous system, in which case they are inClass III, or to supply energy in the form of ionizingradiation in which case they are in Class IIb, or to have a biological effect or to be wholly ormainly absorbed in which case they are in ClassIII, or to undergo chemical change in the body,except if the devices are placed in the teeth, or toadminister medicines, in which case they are inClass IIb.所有外科侵入性器械的短期使用是属IIa类：无论是专门控制，诊断，监测或纠正心脏或循环系统的缺陷，通过直接与身体的这些部分接触，在这种情况下，他们属于III类或专门用于与中枢神经系统直接接触，在这种情况下，他们属于III类或用电离辐射的方式提供能量的形式，这种情况下属于IIb类或有一个生物效应或完全或主要吸收的情况下，他们属于III类或经过体内的化学变化，除非该设备被放置在牙齿上，或管理的药品，在这种情况下，他们属于IIb类。2.4 Rule 8All implantable devices and long-term surgicallyinvasive devices are in Class IIb unless they areintended: to be placed in the teeth, in which case they arein Class IIa, to be used in direct contact with the heart, thecentral circulatory system or the central nervoussystem, in which case they are in Class III, to have a biological effect or to be wholly ormainly absorbed, in which case they are in ClassIII, or to undergo chemical change in the body,except if the devices are placed in the teeth, or toadminister medicines, in which case they are inClass III.所有的可植入装置和长期的外科侵入性装置属于IIb类，除非他们是用于：被放置在牙齿上，在这种情况下，他们属于IIa类，与心脏直接接触，中枢循环系统或中枢神经系统，在这种情况下，他们属于III类有生物效应或将全部或大部分被吸收，在这种情况下，他们属于III类或在体内发生化学变化，除非这些设备被放置在牙齿上，或管理药物，在这种情况下，他们属于III类Additional rules applicable to active devices 额外的规则适用于活性装备3.1 Rule 9All active therapeutic devices intended to administeror exchange energy are in Class IIa unless theircharacteristics are such that they may administer orexchange energy to or from the human body in apotentially hazardous way, taking account of thenature, the density and site of application of theenergy, in which case they are in Class IIb.All active devices intended to control or monitor theperformance of active therapeutic devices in Class IIb,or intended directly to influence the performance ofsuch devices are in Class IIb. 所有用于控制或交换能量的活性设备是属于IIa类，除非他们的特点就是他们可以管理人体的潜在危险或交换能量或以账户的性质、密度和能源应用的网站，在这种情况下，他们在IIb类。所有的活性器件，用来控制或监视的活性治疗器械属于IIb类，或意图直接影响这些设备的性能的也属于IIb类3.2 Rule 10Active devices intended for diagnosis are in ClassIIa: if they are intended to supply energy which willbe absorbed by the human body, except fordevices used to illuminate the patients body, in the visible spectrum, f they are intended to image in vivo distributionof radiopharmaceuticals, if they are intended to allow direct diagnosis ormonitoring of vital physiological processes,unless they are specifically intended formonitoring of vital physiological parameters,where the nature of variations is such that it couldresult in immediate danger to the patient, forinstance variations in cardiac performance,respiration, activity of CNS in which case they arein Class IIb.Active devices intended to emit ionizing radiationand intended for diagnostic and therapeuticinterventional radiology including devices whichcontrol or monitor such devices, or which directlyinfluence their performance, are in Class IIb.用于诊断的活性器械属于IIa类：如果他们的目的是提供能量被人体吸收，除了用可见光谱下照射人身体的设备。如果他们的目的是放射性药物在体内分布的图像如果他们的目的是允许直接诊断或监测重要的生理过程，除非他们是专门用于监测重要的生理参数和其中的变化的性质，导致它可以对病人的直接危害结果，例如心脏的性能变化，呼吸，中枢神经系统在这种情况下，他们属于IIb类。活性器械设计用于发射电离辐射和用于诊断和治疗介入放射学，包括设备监控或控制这些设备，或直接影响其性能，都属于IIb类Rule 11All active devices intended to administer and/orremove medicines, body liquids or other substancesto or from the body are in Class IIa, unless this isdone in a manner: that is potentially hazardous, taking account ofthe nature of the substances involved, of thepart of the body concerned and of the mode ofapplication in which case they are in Class IIb.所有从身体里面施用和/或移除药物，体液或其他物质的活性装备属于IIa类，除非这是在下面这个一个方式完成：即潜在的危险，考虑所涉及的物质的性质的帐户，有关机构和应用程序的模式在这种情况下，它们是在IIb类的部分。3.3 Rule 12All other active devices are in Class I. 所有其它活性装备件属于I类。Special Rules4.1 Rule 13All devices incorporating, as an integral part, asubstance which, if used separately, can beconsidered to be a medicinal product, as defined inArticle 1 of Directive 2001/83/EC, and which isliable to act on the human body with actionancillary to that of the devices, are in Class III.All devices incorporating, as an integral part, a humanblood derivative are in Class III.所有合并产物作为一个组成部分，其中如果分开单独使用，可以被认为是一种药用产品。 如在2001/83/ EC中第1条所定义的物质，并且其易于与作用于人体的设备行动附属于该装置，属于III类。合并产物作为一个组成部分，一个人血液衍生物的所有设备都在III类。4.2 Rule 14All devices used for contraception or the preventionof the transmission of sexually transmitted diseasesare in Class IIb, unless they are implantable or longterm invasive devices, in which case they are in ClassIII.所有用于避孕或预防性病传播的设备都属于IIb类，除非他们是植入或长期侵入的装置，在这种情况下，他们都属于III类。4.3.