Identification of medical device characteristics

1、H&M Hennes & Mauritz GBC AB16(16)Identification of medical device characteristics醫(yī)療器械特性的識別RevDateNameCommentA01XXCreated Identification of characteristics (EN ISO 14971:2012)特性識別1What is the intended use and how is the medical device to be used? 醫(yī)療器械的預期用途是什么?醫(yī)療器械如何使用?Factors that should be c

2、onsidered include: 需要考慮到的因素包括- what is the medical device's role relative to -醫(yī)療器械所扮演的角色與下列哪個相關- diagnosis, prevention, monitoring, treatment or alleviation of disease, -疾病的診斷, 預防,監(jiān)護,治療或緩解- compensation for injury or handicap or -對創(chuàng)傷或殘疾進行補償- replacement or modification of anatomy, or control of

3、conception? -解剖過程的替代或矯正, 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? -醫(yī)療器械是否用于生命維持?- is special intervention necessary in the case of failure of the medical device? -如果器械失效是否有必要進行特殊的干預Product description:產品描述Pat

4、ient group:患者群User:使用者Need for education? 需要教育Environment: 環(huán)境 Installation? 安裝2Is the medical device intended to be implanted? 醫(yī)療器械是否預期用于植入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. 需要考慮的因素包括植入的位置,患者群的特點、年齡、體重、身體機能,年老對植入性能的影響, 植入物的預期壽命, 植入物是否可取出YES/NO Motivation/description 動機/描述3Is the medical device intended to be in contact with the patient or other persons? 醫(yī)療器械是否

6、預期和患者或其他人接觸?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需要考慮的因素包括預期接觸的性質, (即表面接觸,有創(chuàng)接觸,或者植入), 以及每種接觸的時間和接觸的頻次.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? 在醫(yī)療器械中用到了何種材料或部件? 或何種材料或部件與醫(yī)療器械共同使用,或與產品接觸Factors that should be considered include: 需要考慮的因素- compatibility with relevant substances; -與相關物質的兼容性- compatibility with tissues or body fluids; -與組織或體

8、液的兼容性- whether characteristics relevant to safety are known; -與安全相關的特性是否已知- is the device manufactured utilizing materials of animal origin? 器械制造是否使用了動物器官5Is energy delivered to or extracted from the patient? 是否有能量給予患者或從患者身上獲取Factors that should be considered include: 應考慮的因素- the type of energy tran

9、sferred; -能量傳遞的形式- its control, quality, quantity, intensity and duration; -其控制, 質量, 數量 ,強度和持續(xù)時間- whether energy levels are higher than those currently used for similar devices. -其能量等級是否高于相似醫(yī)療器械的能量等級6Are substances delivered to or extracted from the patient? 是否有物質提供給患者或從患者身上提取?Factors that should be

10、 considered include應考慮的因素- whether the substance is delivered or extracted; -物質是提供還是提取- whether it is a single substance or range of substances; -是單一物質還是一系列物質- the maximum and minimum transfer rates and control thereof. -最大和最小傳遞率及控制7Are biological materials processed by the medical device for subseq

11、uent re-use, transfusion or transplantation? 是否由醫(yī)療器械處理生物材料并用于再次使用、輸送或移植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). 應考慮的因素包括處理的方式和被處理物質的類型(例如,自動輸血,透析, 血液成分或細胞的治療處理)8Is the medic

12、al device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable? 醫(yī)療器械是否以無菌形式提供或預期由使用者滅菌,或采用其他微生物控制方法?Factors that should be considered include應考慮的因素包括- whether the medical device is intended for single use or re-use packaging; -醫(yī)療器械是預期一次性使用還是重復使用

13、的包裝形式- shelf-life issues; -貨架壽命問題- limitation on the number of re-use cycles; -重復使用次數的限制- method of product sterilization; -產品滅菌方法- the impact of other sterilization methods not intended by the manufacturer. -制造商預期之外的方法進行滅菌的影響9Is the medical device intended to be routinely cleaned and disinfected by

14、 the user? 醫(yī)療器械是否預期由用戶進行常規(guī)清潔和消毒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. 應考慮的因素包括：所使用的清潔或消毒劑的類型和消毒次數的限制。醫(yī)療器械的設計也可能影響日常清潔和消毒的有效性。此外, 還需要考慮到清潔或消毒劑對器械的安全性或性能的影響10Is the medical device intended to modify the patient environment? 器械是否預期改善患者的環(huán)境Factors that

16、 should be considered include: 應考慮的因素包括- temperature; -溫度- humidity; -濕度- atmospheric gas composition; -大氣成分- pressure; -壓力- light. -光線11Are measurements taken? 是否進行測量Factors that should be considered include the variables measured and the accuracy and the precision of themeasurement results. 需考慮的因素

17、包括：測量的變量和測量結果的準確度和精確度12Is the medical device interpretative? 器械是否進行分析處理(解釋)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. 應考慮的因素包括:醫(yī)療器械是否由輸入或獲得的數據顯示結論, 所使用的算法和置信界限。應特別注意非預期的算法和數據的使用13Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies? 器械是否預期與其他器械,醫(yī)藥或醫(yī)療技術聯(lián)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. 應考慮的因素包括：識別可能使用的的醫(yī)療器械,醫(yī)藥或其他醫(yī)療技術,與這些相互作用相關的潛在問題, 以及病人對治療的順從性14Are there unwanted outputs of energy or substan

20、ces? 是否由不希望的能量或物質輸出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. 應考慮的與能量相關的因素包括：噪音和振動, 熱量, 輻射(包括電離輻

22、射,非電離輻射和紫外/可見/紅外輻射), 接觸溫度, 漏電流和電(磁)場。 應考慮的與物質相關的因素包括：制造、清潔或測試過程中使用的物質, 如果繼續(xù)保存在產品上可能會有不希望的生理影響。 還應考慮的與物質相關的因素包括：化學物質、廢物和體液的排放15Is the medical device susceptible to environmental influences? 醫(yī)療器械是否對環(huán)境影響敏感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. 應考慮的因素包括：操作、運輸和儲存環(huán)境。包括：光線，溫度，濕度，振動，泄漏，對能源和致冷供應的變化的敏感性，以及電磁干擾16Does the medical device influence the environment? 醫(yī)療器械是否影響環(huán)境Factors that should

24、be considered include: 應考慮的因素包括- the effects on power and cooling supplies; -對能源和致冷供應的影響- emission of toxic materials; -毒性物質的散發(fā);- the generation of electromagnetic disturbance -電磁干擾的產生17Are there essential consumables or accessories associated with the medical device? 醫(yī)療器械是否有與之相關的基本耗材或附件Factors that

25、 should be considered include specifications for such consumables or accessories and any restrictions placed upon users in their selection of these. 應考慮的因素包括:消耗品或附件的規(guī)范以及對使用者選擇它們的限制18Is maintenance or calibration necessary? 是否有必要進行維護或校準Factors that should be considered include: 應考慮的因素包括- whether main

26、tenance or calibration are to be carried out by the operator or user or by a specialist; -維護或校準由誰來實行,操作者、使用者還是專家- are special substances or equipment necessary for proper maintenance or calibration? -適當的維護是否需要特殊的物質或設備19Does the medical device contain software? 醫(yī)療器械是否包括軟件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. 應考慮的因素包括：軟件預期由誰來安裝、驗證、修改或更換，操作者、使用者還是專家？20Does the medical device have a restricted shelf-life? 醫(yī)療器械是否有儲存壽命限制Factors that should be considered include labelling or i

28、ndicators and the disposal of such medical devices when the expiration date is reached. 應考慮的因素包括：標簽或指示物, 以及到達有效期的處置21Are there any delayed or long-term use effects? 是否有延遲或長期使用效應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. 應考慮的因素包括：人機工程學和累積效應。例如：鹽水泵隨著時間腐蝕, 機械疲勞,扎帶或附件的松動,振動效應,標簽磨損或掉落,長期材料降解22To what mechanical forces will the medical device be subjected? 醫(yī)療器械承受何種機械力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. 應考慮的因素包括： 醫(yī)療器械承受的力是否在使用者的控制下或由其他人員的相互作用來控制23What determines the lifetime of the medical device? 什么決定醫(yī)療器械的壽命?Fac

31、tors that should be considered include ageing and battery depletion. 應考慮到的因素包括：老化和電池損耗24Is the medical device intended for single use? 器械是否預期一次性使用Factors that should be considered include: does the medical device self-destruct after use? Is it obvious that the device has been used? 應考慮的因素包括：器械使用后是否自

32、毀?是否能明顯看出器械使用過25Is safe decommissioning or disposal of the medical device necessary? 器械是否需要安全的退出使用或處置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? 應考慮的因素包括：醫(yī)療器械本身進行處置時產生的廢物。例如, 是否含有毒性或有害材料,材料是否可再循環(huán)使用 26Does installation or use of the medical device require special training or special skills? 器械的安裝或使用是否需要經過專門培訓或專門的技能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. 應考慮的因素包括：器械的新穎之處和安裝器械的人可能具有的技能和經過的培訓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: 應考慮到的因素包括- 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; -信息是直接提供給最終用戶還是涉及到第三方的加入（例如安裝者,護理者,保健專家或藥劑師）;是否意味著需要培訓- 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; -調試和移交給最終用戶;是否可能出現(xiàn)不具備必要技能的人進行安裝的情況- based on the expected life of the device, whether re-training or re-certification of operators or service personnel would be required. -考慮到器械的預期壽命, 是否需要對操作者或服務人員進行再培訓或再認證28Will new manufacturing pro

37、cesses need to be established or introduced? 是否需要建立或引入新的生產過程Factors that should be considered include new technology or a new scale of production. 應考慮到的因素包括：新技術或新生產規(guī)模29Is successful application of the medical device critically dependent on human factors such as the user interface? 醫(yī)療器械的成功使用,是否決定性的取決

38、于人為因素,例如使用者接口29.1Can the user interface design features contribute to use error? 用戶接口的設計特征是否可能導致使用錯誤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. 應考慮的因素包括：可能造成使用錯誤的用戶接口設計特征。用戶接口設計特征包括：控制和指示物(器), 使用的符號, 人機工程學特性, 物理設計和布局, 操作的級別, 軟件驅動器械的菜單, 警告的可視性, 警報的可聽性, 顏色編碼的標準化29.2Is the

40、 medical device used in an environment where distractions can cause use error? 在器械的使用環(huán)境中, 是否會因分心而導致使用錯誤Factors that should be considered include: 應考慮的因素包括- the consequence of use error; -使用錯誤的后果- whether the distractions are commonplace; -是否這些導致分心的事情很平常- whether the user can be disturbed by an infre

41、quent distraction. -用戶是否會被不尋常的事情干擾29.3Does the medical device have connecting parts or accessories? 醫(yī)療器械是否有連接部件或附件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. 應考慮的因素包括：錯誤連接的可能性,與其他產品連接的類似性, 連接力, 對連接完整性的反饋, 以及過緊或過松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. 應考慮的因素包括：間隔、編碼、分組、圖形顯示、反饋模式、出錯、疏忽、控制的區(qū)別、可視性、啟動或變換的方向，控制是連續(xù)的還是斷續(xù)的，設定或動作的可逆性（可取消性）29.5Does the medical device display information? 醫(yī)療器械是否顯示信息?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. 應考慮的因素包括： 在不同情況下的的可視性(包括不同的環(huán)境,不同的方向,不同的使用者視力,不同的人群和觀察力),顯示信息的清晰度,單位,顏色編碼,以及危急

45、信息的可到達性。29.6Is the medical device controlled by a menu? 醫(yī)療器械是否由菜單控制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. 應考慮到的因素包括： 層次的復雜性和層數, 狀態(tài)的了解, 設置(所在)的路徑, 導航方法,每一動作的步驟數, 順序的清晰度和記憶問題, 與其可達到性相關的控制功能的重要性, 以及偏離指定操作規(guī)程的影響29.7Will the medical device be used by persons with special needs? 醫(yī)療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? 應考慮的因素包括：使用者, 他們的智力和身體能力、技能和培訓, 人機工程學, 使用境,安裝要求, 以及患者控制或影響醫(yī)療器械使用的能力。 應特別注意有特殊需求的使用者,如殘疾人,老年人和兒童。他們的特殊需求可能包括在旁人幫助下使用醫(yī)療器械。器械是否預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? 否預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