MDD_Classification_Chart.doc

MDD Art. 9, ANNEX IX III. Classification Performer: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/NA Description Non-invasive devices非侵略性设备 1.1 Rule 1 All non-invasive devices are in Class I, unless one of 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 2 All non-invasive devices intended for channeling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa: if they may be connected to an active medical device in Class IIa or a higher class, if they are intended for use for storing or channeling blood or other body liquids or for storing organs, parts of organs or body tissues, in all 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 3 All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of 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