Identification of medical device characteristics

1、H&M Hennes & Mauritz GBC AB16(16)Identification of medical device characteristics医疗器械特性的识别RevDateNameCommentA01XXCreated Identification of characteristics (EN ISO 14971:2012)特性识别1What 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 c

2、onsidered include: 需要考虑到的因素包括- what is the medical device's 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

3、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Pat

4、ient group:患者群User:使用者Need for education? 需要教育Environment: 环境 Installation? 安装2Is 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

5、 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3Is the medical device intended to be in contact with the patient or other persons? 医疗器械是否

6、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/description4What materials or com

7、ponents 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 be considered include: 需要考虑的因素- compatibility with relevant substances; -与相关物质的兼容性- compatibility with tissues or body fluids; -与组织或体

8、液的兼容性- whether characteristics relevant to safety are known; -与安全相关的特性是否已知- is the device manufactured utilizing materials of animal origin? 器械制造是否使用了动物器官5Is energy delivered to or extracted from the patient? 是否有能量给予患者或从患者身上获取Factors that should be considered include: 应考虑的因素- the type of energy tran

9、sferred; -能量传递的形式- its control, quality, quantity, intensity and duration; -其控制, 质量, 数量 ,强度和持续时间- whether energy levels are higher than those currently used for similar devices. -其能量等级是否高于相似医疗器械的能量等级6Are substances delivered to or extracted from the patient? 是否有物质提供给患者或从患者身上提取?Factors that should be

10、 considered include应考虑的因素- whether the substance is delivered or extracted; -物质是提供还是提取- whether it is a single substance or range of substances; -是单一物质还是一系列物质- the maximum and minimum transfer rates and control thereof. -最大和最小传递率及控制7Are biological materials processed by the medical device for subseq

11、uent re-use, transfusion or transplantation? 是否由医疗器械处理生物材料并用于再次使用、输送或移植Factors that should be considered include the type of process and substance(s) processed (e.g. auto transfusion, dialysis, blood component or cell therapy processing). 应考虑的因素包括处理的方式和被处理物质的类型(例如,自动输血,透析, 血液成分或细胞的治疗处理)8Is the medic

12、al device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable? 医疗器械是否以无菌形式提供或预期由使用者灭菌,或采用其他微生物控制方法?Factors that should be considered include应考虑的因素包括- whether the medical device is intended for single use or re-use packaging; -医疗器械是预期一次性使用还是重复使用

13、的包装形式- shelf-life issues; -货架寿命问题- limitation on the number of re-use cycles; -重复使用次数的限制- method of product sterilization; -产品灭菌方法- the impact of other sterilization methods not intended by the manufacturer. -制造商预期之外的方法进行灭菌的影响9Is the medical device intended to be routinely cleaned and disinfected by

14、 the user? 医疗器械是否预期由用户进行常规清洁和消毒Factors that should be considered include the types of cleaning or disinfecting agents to be used and any limitations on the number of cleaning cycles. The design of the medical device can influence the effectiveness of routine cleaning and disinfection. In addition, c

15、onsideration should be given to the effect of cleaning and disinfecting agents on the safety or performance of the device. 应考虑的因素包括：所使用的清洁或消毒剂的类型和消毒次数的限制。医疗器械的设计也可能影响日常清洁和消毒的有效性。此外, 还需要考虑到清洁或消毒剂对器械的安全性或性能的影响10Is the medical device intended to modify the patient environment? 器械是否预期改善患者的环境Factors that

16、 should be considered include: 应考虑的因素包括- temperature; -温度- humidity; -湿度- atmospheric gas composition; -大气成分- pressure; -压力- light. -光线11Are measurements taken? 是否进行测量Factors that should be considered include the variables measured and the accuracy and the precision of themeasurement results. 需考虑的因素

17、包括：测量的变量和测量结果的准确度和精确度12Is the medical device interpretative? 器械是否进行分析处理(解释)Factors that should be considered include whether conclusions are presented by the medical device from input or acquired data, the algorithms used, and confidence limits. Special attention should be given to unintended applic

18、ations of the data or algorithm. 应考虑的因素包括:医疗器械是否由输入或获得的数据显示结论, 所使用的算法和置信界限。应特别注意非预期的算法和数据的使用13Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies? 器械是否预期与其他器械,医药或医疗技术联合使用Factors that should be considered include identifying any ot

19、her medical devices, medicines or other medical technologies that can be involved and the potential problems associated with such interactions, as well as patient compliance with the therapy. 应考虑的因素包括：识别可能使用的的医疗器械,医药或其他医疗技术,与这些相互作用相关的潜在问题, 以及病人对治疗的顺从性14Are there unwanted outputs of energy or substan

20、ces? 是否由不希望的能量或物质输出Energy-related factors that should be considered include noise and vibration, heat, radiation (includingionizing, non-ionizing, and ultraviolet/visible/infrared radiation), contact temperatures, leakage currents, andelectric or magnetic fields.Substance-related factors that should

21、 be considered include substances used in manufacturing, cleaning ortesting having unwanted physiological effects if they remain in the product.Other substance-related factors that should be considered include discharge of chemicals, waste products,and body fluids. 应考虑的与能量相关的因素包括：噪音和振动, 热量, 辐射(包括电离辐

22、射,非电离辐射和紫外/可见/红外辐射), 接触温度, 漏电流和电(磁)场。 应考虑的与物质相关的因素包括：制造、清洁或测试过程中使用的物质, 如果继续保存在产品上可能会有不希望的生理影响。 还应考虑的与物质相关的因素包括：化学物质、废物和体液的排放15Is the medical device susceptible to environmental influences? 医疗器械是否对环境影响敏感Factors that should be considered include the operational, transport and storage environments. The

23、se include light, temperature, humidity, vibrations, spillage, susceptibility to variations in power and cooling supplies, and electromagnetic interference. 应考虑的因素包括：操作、运输和储存环境。包括：光线，温度，湿度，振动，泄漏，对能源和致冷供应的变化的敏感性，以及电磁干扰16Does the medical device influence the environment? 医疗器械是否影响环境Factors that should

24、be considered include: 应考虑的因素包括- the effects on power and cooling supplies; -对能源和致冷供应的影响- emission of toxic materials; -毒性物质的散发;- the generation of electromagnetic disturbance -电磁干扰的产生17Are there essential consumables or accessories associated with the medical device? 医疗器械是否有与之相关的基本耗材或附件Factors that

25、 should be considered include specifications for such consumables or accessories and any restrictions placed upon users in their selection of these. 应考虑的因素包括:消耗品或附件的规范以及对使用者选择它们的限制18Is maintenance or calibration necessary? 是否有必要进行维护或校准Factors that should be considered include: 应考虑的因素包括- whether main

26、tenance or calibration are to be carried out by the operator or user or by a specialist; -维护或校准由谁来实行,操作者、使用者还是专家- are special substances or equipment necessary for proper maintenance or calibration? -适当的维护是否需要特殊的物质或设备19Does the medical device contain software? 医疗器械是否包括软件Factors that should be consid

27、ered include whether software is intended to be installed, verified, modified or exchanged by the operator or user or by a specialist. 应考虑的因素包括：软件预期由谁来安装、验证、修改或更换，操作者、使用者还是专家？20Does the medical device have a restricted shelf-life? 医疗器械是否有储存寿命限制Factors that should be considered include labelling or i

28、ndicators and the disposal of such medical devices when the expiration date is reached. 应考虑的因素包括：标签或指示物, 以及到达有效期的处置21Are there any delayed or long-term use effects? 是否有延迟或长期使用效应Factors that should be considered include ergonomic and cumulative effects. Examples could include pumps for saline that co

29、rrode over time, mechanical fatigue, loosening of straps and attachments, vibration effects, labels that wear or fall off, long term material degradation. 应考虑的因素包括：人机工程学和累积效应。例如：盐水泵随着时间腐蚀, 机械疲劳,扎带或附件的松动,振动效应,标签磨损或掉落,长期材料降解22To what mechanical forces will the medical device be subjected? 医疗器械承受何种机械力F

30、actors that should be considered include whether the forces to which the medical device will be subjected are under the control of the user or controlled by interaction with other persons. 应考虑的因素包括： 医疗器械承受的力是否在使用者的控制下或由其他人员的相互作用来控制23What determines the lifetime of the medical device? 什么决定医疗器械的寿命?Fac

31、tors that should be considered include ageing and battery depletion. 应考虑到的因素包括：老化和电池损耗24Is the medical device intended for single use? 器械是否预期一次性使用Factors that should be considered include: does the medical device self-destruct after use? Is it obvious that the device has been used? 应考虑的因素包括：器械使用后是否自

32、毁?是否能明显看出器械使用过25Is safe decommissioning or disposal of the medical device necessary? 器械是否需要安全的退出使用或处置Factors that should be considered include the waste products that are generated during the disposal of the medical device itself. For example, does it contain toxic or hazardous material, or is the m

33、aterial recyclable? 应考虑的因素包括：医疗器械本身进行处置时产生的废物。例如, 是否含有毒性或有害材料,材料是否可再循环使用 26Does installation or use of the medical device require special training or special skills? 器械的安装或使用是否需要经过专门培训或专门的技能Factors that should be considered include the novelty of the medical device and the likely skill and training

34、of the person installing the device. 应考虑的因素包括：器械的新颖之处和安装器械的人可能具有的技能和经过的培训27How will information for safe use be provided? 安全使用信息是如何提供的Factors that should be considered include: 应考虑到的因素包括- whether information will be provided directly to the end user by the manufacturer or will it involve theparticip

35、ation of third parties such as installers, care providers, health care professionals or pharmacistsand whether this will have implications for training; -信息是直接提供给最终用户还是涉及到第三方的加入（例如安装者,护理者,保健专家或药剂师）;是否意味着需要培训- commissioning and handing over to the end user and whether it is likely/possible that insta

36、llation can becarried out by people without the necessary skills; -调试和移交给最终用户;是否可能出现不具备必要技能的人进行安装的情况- based on the expected life of the device, whether re-training or re-certification of operators or service personnel would be required. -考虑到器械的预期寿命, 是否需要对操作者或服务人员进行再培训或再认证28Will new manufacturing pro

37、cesses need to be established or introduced? 是否需要建立或引入新的生产过程Factors that should be considered include new technology or a new scale of production. 应考虑到的因素包括：新技术或新生产规模29Is successful application of the medical device critically dependent on human factors such as the user interface? 医疗器械的成功使用,是否决定性的取决

38、于人为因素,例如使用者接口29.1Can the user interface design features contribute to use error? 用户接口的设计特征是否可能导致使用错误Factors that should be considered are user interface design features that can contribute to use error.Examples of interface design features include: control and indicators, symbols used, ergonomic fea

39、tures, physical design and layout, hierarchy of operation, menus for software driven devices, visibility of warnings, audibility of alarms, standardization of colour coding. 应考虑的因素包括：可能造成使用错误的用户接口设计特征。用户接口设计特征包括：控制和指示物(器), 使用的符号, 人机工程学特性, 物理设计和布局, 操作的级别, 软件驱动器械的菜单, 警告的可视性, 警报的可听性, 颜色编码的标准化29.2Is the

40、 medical device used in an environment where distractions can cause use error? 在器械的使用环境中, 是否会因分心而导致使用错误Factors that should be considered include: 应考虑的因素包括- the consequence of use error; -使用错误的后果- whether the distractions are commonplace; -是否这些导致分心的事情很平常- whether the user can be disturbed by an infre

41、quent distraction. -用户是否会被不寻常的事情干扰29.3Does the medical device have connecting parts or accessories? 医疗器械是否有连接部件或附件Factors that should be considered include the possibility of wrong connections, similarity to other products connections, connection force, feedback on connection integrity, and over- an

42、d under-tightening. 应考虑的因素包括：错误连接的可能性,与其他产品连接的类似性, 连接力, 对连接完整性的反馈, 以及过紧或过松29.4Does the medical device have a control interface? 器械是否有控制接口Factors that should be considered include spacing, coding, grouping, mapping, modes of feedback, blunders, slips, control differentiation, visibility, direction of

43、 activation or change, whether the controls are continuous or discrete, and the reversibility of settings or actions. 应考虑的因素包括：间隔、编码、分组、图形显示、反馈模式、出错、疏忽、控制的区别、可视性、启动或变换的方向，控制是连续的还是断续的，设定或动作的可逆性（可取消性）29.5Does the medical device display information? 医疗器械是否显示信息?Factors that should be considered include

44、visibility in various environments, orientation, the visual capabilities of the user, populations and perspectives, clarity of the presented information, units, colour coding, and the accessibility of critical information. 应考虑的因素包括： 在不同情况下的的可视性(包括不同的环境,不同的方向,不同的使用者视力,不同的人群和观察力),显示信息的清晰度,单位,颜色编码,以及危急

45、信息的可到达性。29.6Is the medical device controlled by a menu? 医疗器械是否由菜单控制Factors that should be considered include complexity and number of layers, awareness of state, location of settings, navigation method, number of steps per action, sequence clarity and memorization problems, and importance of control

46、 function relative to its accessibility and the impact of deviating from specified operating procedures. 应考虑到的因素包括： 层次的复杂性和层数, 状态的了解, 设置(所在)的路径, 导航方法,每一动作的步骤数, 顺序的清晰度和记忆问题, 与其可达到性相关的控制功能的重要性, 以及偏离指定操作规程的影响29.7Will the medical device be used by persons with special needs? 医疗器械是否用于有特殊需要的人Factors that

47、should be considered include the user, their mental and physical abilities, skill and training, ergonomic aspects, the use environment, installation requirements, and the patient's capability to control or influence the use of the medical device. Special attention should be paid to users with sp

48、ecial needs, such as handicapped persons, the elderly and children. Their special needs might include assistance by another person to enable the use of a medical device. Is the medical device intended to be used by individuals with various skill levels and cultural backgrounds? 应考虑的因素包括：使用者, 他们的智力和身体能力、技能和培训, 人机工程学, 使用境,安装要求, 以及患者控制或影响医疗器械使用的能力。 应特别注意有特殊需求的使用者,如残疾人,老年人和儿童。他们的特殊需求可能包括在旁人帮助下使用医疗器械。器械是否预期由不同技能水平和教育背景的人使用29.8Can the user interface be used to initiate user actions? 否预期由不同技能水平和教育背景的人使用Factors that should be considered include the possibility of initiating a deli