Identification of medical device characteristics.doc

Identification of medical device characteristics医疗器械特性的识别 Rev Date Name Comment A01 XX Created Identification of characteristics (EN ISO 14971:2012)特性识别 1 What is the intended use and how is the medical device to be used? 医疗器械的预期用途是什么?医疗器械如何使用? Factors that should be considered include: 需要考虑到的因素包括 - what is the medical devices role relative to -医疗器械所扮演的角色与下列哪个相关 - diagnosis, prevention, monitoring, treatment or alleviation of disease, -疾病的诊断, 预防,监护,治疗或缓解 - compensation for injury or handicap or -对创伤或残疾进行补偿 - replacement or modification of anatomy, or control of conception? -解剖过程的替代或矫正, 或妊娠控制 - what are the indications for use (e.g. patient population)? -使用指示是什么?(如患者群) - does the medical device sustain or support life? -医疗器械是否用于生命维持? - is special intervention necessary in the case of failure of the medical device? -如果器械失效是否有必要进行特殊的干预 Product description:产品描述 Patient group:患者群 User:使用者  Need for education? 需要教育 Environment: 环境 Installation? 安装 2 Is the medical device intended to be implanted? 医疗器械是否预期用于植入 Factors that should be considered include the location of implantation, the characteristics of the patient population, age, weight, physical activity, the effect of ageing on implant performance, the expected lifetime of the implant, the reversibility of the implantation. 需要考虑的因素包括植入的位置,患者群的特点、年龄、体重、身体机能,年老对植入性能的影响, 植入物的预期寿命, 植入物是否可取出 YES/NO Motivation/description 动机/描述 3 Is the medical device intended to be in contact with the patient or other persons? 医疗器械是否预期和患者或其他人接触? Factors that should be considered include the nature of the intended contact, i.e. surface contact, invasive contact, or implantation and, for each, the period and frequency of contact需要考虑的因素包括预期接触的性质, (即表面接触,有创接触,或者植入), 以及每种接触的时间和接触的频次. YES/NO Motivation/description 4 What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device? 在医疗器械中用到了何种材料或部件? 或何种材料或部件与医疗器械共同使用,或与产品接触 Factors that should