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1、精品文档,仅供学习与交流,如有侵权请联系网站删除EN 62366:2008 Checklist/检查表Medical devicesApplication of usability engineering to medical devices可用性工程于医疗器械的应用Report Reference No/编号.:版本号: 验证人:Date of issue/发布日期:Test item description/项目:Model/Type reference/型号:Abbreviations used in the report/缩写:- Usability Engineering/可用性工程
2、: UE- Risk analysis/风险分析: RA- User interface/用户界面: UI- Risk management/风险管理: RM- Primary operating function/主要操作功能: POFGeneral product information/产品描述:版本修改记录:日期版本说明验证人审批人 【精品文档】第 11 页4GENERAL REQUIREMENTS/总要求4.1General Requirements/总要求4.1.1Usability Engineering Process/可用性工程过程Has the manufacturer e
3、stablished, documented and maintained a usability engineering process to provide Safety for the patient, user and others related to usability for the product?制造商是否建立、记录并维持了一个可用性工程过程,以确保患者、用户和其它涉及产品适用性的人的安全?Does the Process address user interactions with the medical device according to the accompanyi
4、ng document including, but not limited to transport, storage, installation, operation, maintenance, repair and disposal?该过程是否用于解决用户按随机文件与医疗器械的交互,如运输、存储、安装、操作、维护、维修和废弃?4.1.2Are Residual Risks associated with Usability of the medical Device presumed to be acceptable, unless there is objective evidence
5、 to the contrary and documented?关系医疗器械可用性的剩余风险是否推定可接受?4.1.3manufacturer shall subject the information for safety used as a risk control to the usability engineering process (e.g., warnings or limitation of use in the accompanying documents, marking, etc.).对于做为风险控制措施的安全信息,制造商应把它纳入可用性工程过程的控制Disregardi
6、ng such information for safety is considered beyond any further reasonable means of risk control忽视安全信息的行为应被认为是超出风险控制措施的(即非正常使用)4.2The results of the usability engineering process are recorded in the usability engineering file可用性工程过程的结果记录于可用性工程文档。The records and other documents that make up the usabi
7、lity engineering file may form part of other documents and files (e.g., a manufacturers product design file or risk management file), (see List of documents make up the UE file)组成可用性工程文档的记录和其它文件可以是其它文档(如技术文档和风险管理文档)的一部分4.3Scaling of the Usability Engineering effort/可用性工程的调整The usability engineering
8、process is scaled based on the significance of any modifications depending on the results of the risk analysis and documented可用性工程调整取决于风险分析确认的设计更改的重要程度5USABILTY ENGINEERING PROCESS/可用性工程过程5.1Application specification/应用的规格Application of Medical Device in the usability engineering file is specified b
9、y the manufacturer and includes可用性工程文档中的医疗器械的应用由制造商决定,包括: intended medical indication (e.g., conditions(s) or disease(s) to be screened, monitored, treated, diagnosed, or prevented);预期医学用途,如预期要筛查、监护、治疗、诊断或预防的状态或疾病; intended patient population (e.g., age, weight, health, condition);预期患者群,如年龄、体重、健康和社会
10、条件; intended part of the body or type of tissue applied to or interacted with;预期使用的身体部位或组织; intended conditions of use (e.g. environment including hygienic requirements, frequency of use, location, mobility); and预期的使用状态,如环境包括卫生要求、使用频度、地点和机动性; operating principle(s)操作原理5.2Frequently used functions/常用
11、功能Are frequently used functions that involve User interaction with the Medical Device are determined and recorded in the usability engineering file?在可用性工程文档中是否确定并记录了涉及用户与医疗器械交互的常用功能?5.3Identification of hazards and hazardous situations related to usability/识别可用性相关的危害和危害处境5.3.1Identification of chara
12、cteristics to safety/识别安全特征Identification of characteristics related to safety (part of a risk analysis) that focuses on usability performed according to ISO 14971:2007, 4.2.应按ISO 14971:2007, 4.2的要求识别专注于可用性的安全特征During the identification characteristics related to safety, the following are considered
13、:在识别安全特征时,要考虑下列因素: application specification, including user profile(s); and应用的规格,包括用户特征;frequently used functions.常用功能。Results of this identification characteristics related to safety recorded in the usability engineering file安全特征识别的结果应记录于可用性工程文档 5.3.2Identification of known or foreseeable hazards
14、and hazardous situations/识别已知的或可预见的危害和危害处境manufacturer has identified known or foreseeable hazards (part of a risk analysis) related to usability according to ISO 14971:2007, 4.3.制造商要按ISO 14971:2007, 4.3的要求识别可用性相关的已知的或可预见的危害Identification of hazards considered hazards to patients, users and other pe
15、rsons 识别危害时要考虑对患者、操作者和其他人员的危害N/AReasonably foreseeable sequences or combinations of events involving the user INTERFACE that can result in a HAZARDOUS SITUATION associated with the MEDICAL DEVICE were identified. The SEVERITY of the resulting possible HARM is determined.包括可能导致危害处境的医疗器械用户界面的合理可预见的事件的
16、次序和组合已经被识别。导致的可能的危害的严重程度已确定。During the identification of HAZARDS and HAZARDOUS SITUATIONS, the following was considered:在识别危害和危害处境时,下列需要考虑: application specification, including user rofile(s);应用的规格,包括用户特征; task related requirements;任务相关的要求; context of use;使用的背景; information on HAZARDS and HAZARDOUS
17、SITUATIONS known for existing USER INTERFACES of MEDICAL DEVICES of a similar type, if available;对于现存的类似的医疗器械用户界面的已知的危害和危害处境信息; preliminary USE SCENARIOS;初步的使用情景; possible USE ERRORS;可能的使用错误; if an incorrect mental model of the operation of the MEDICAL DEVICE can cause a USE ERROR resulting in a HAZ
18、ARDOUS SITUATION; and操作医疗器械的错误精神模型是否会引起导致危害处境的使用错误; results of the review of the USER INTERFACE用户界面的评审结果。The results of this identification of HAZARDS, HAZARDOUS SITUATIONS and SEVERITY are recorded in the USABILITY ENGINEERING FILE.识别危害、危害处境和严重程度的结果要记录在可用性工程文档里。5.4Primary operating functions/主要操作功能
19、The manufacturer has determined the primary operating functions and recorded in the usability engineering file制造商已经确定了主要操作功能并记录在可用性工程文档里。The inputs to the primary operating functions include frequently used functions and functions related to Safety of the Medical Device主要操作功能的输入包括常用功能和关系医疗器械安全的功能。5.
20、5Usability Specification/可用性规范manufacturer developed a usability specification recorded in the usability engineering file as part of the usability engineering process制造商应制定可用性规范,记录于可用性工程文档里作为可用性工程过程的一部分。The usability specification recorded in usability engineering file. The usability specification m
21、ay be integrated into other specifications可用性规范记录于可用性工程文档里。可用性规范可以整合于其它规范。The usability specification includes: 可用性规范包括: application specification;应用的规格; primary operating functions主要操作功能 hazards and Hazardous Situations related to the Usability; and关系可用性的危害和危害处境 known or foreseeable use errors asso
22、ciated with the Medical Device已知的或可预见的关系医疗器械的使用错误。The usability specification describes at least:可用性规范至少要描述: use scenarios related to the primary operating functions, including 关于主要操作功能的使用情景,包括: frequent Use Scenarios, and 常见的使用情景 reasonably foreseeable worst case Use Scenarios; 合理可预见的最坏使用情景; User I
23、nterface requirements for the primary operating functions, including those to mitigate Risk;主要操作功能对于用户界面的要求,包括降低风险的那些; Requirements for determining whether primary operating functions are easily recognizable by the User.用于决定主要操作功能是否易于被用户认知的要求5.6Usability validation plan/可用性确认计划The manufacturer has d
24、eveloped and maintains a usability validation plan specifying:制造商需制定并维护可用性确认计划,以规定: any method used for validation of the usability of the primary operating functions;对于主要操作功能的可用性的确认方法; the criteria for determining successful validation of the usability of the primary operating functions based on th
25、e usability specification; and基于可用性规范,对主要操作功能可用性的确认标准 the involvement of representative intended users 包含的预期用户代表usability validation performed in a laboratory setting:可用性确认实施的实验室设置:usability validation performed in a simulated use environment:可用性确认实施于模拟使用环境:usability validation performed in the actu
26、al use environment:可用性确认实施于真实使用环境:The usability validation plan addresses: 可用性确认计划包括: frequent Use Scenarios, and常见的使用情景; reasonably foreseeable worst case use scenarios合理可预见的最坏使用情景that are identified in the usability specification都要在可用性规范中识别。The usability validation plan recorded in the usability e
27、ngineering file可用性确认计划应记录与可用性工程文档。5.7User interface design and implementation/用户界面设计和实施Manufacturer designed and implemented the user interface as described in the usability Specification utilizing, as appropriate, usability engineering methods and techniques制造商应使用可用性工程的方法和技术来开发并实施可用性规范描述的用户界面。5.8Us
28、ability verification /可用性验证Manufacturer verified the implementation of the Medical Device User interface design according to the usability specification制造商应根据可用性规范来验证医疗器械用户界面设计的实施。The results of the verification are recorded in usability engineering file验证的结果应记录于可用性工程文档。5.9Usability Validation/可用性确认
29、The manufacturer has validated the Usability of the Medical Device according to the usability validation plan制造商应根据可用性确认计划来确认医疗器械用户界面的可用性。The results are recorded in the usability engineering file确认的结果应记录于可用性工程文档。For the acceptance criteria documented in the usability validation plan that are not me
30、t:对于没有可用性确认计划中制定的未被满足的接收准则:- further User Interface design and implementation activities are performed; or需要进行进一步的用户界面设计和执行;或- if further improvement is not practicable, the MANUFACTURER may gather and review data and literature to determine if the medical benefits of the INTENDED USE outweigh the R
31、ISK arising from USABILITY problems如果进一步的改进不现实,制造商需要收集并评审数据和文献,以确定预期用途的医疗收益是否超过可用性问题带来的风险。To perform this step, the MANUFACTURER needs to estimate the RISK arising from USABILITY problems.为此,制造商需评估可用性问题带来的风险。6ACCOMPANYING DOCUMENTS/随机文件The Accompanying document includes a summary of the Medical Devi
32、ce application specification随机文件应包括医疗器械应用的规格的总结。A concise description of the Medical Device, its operating principles, significant physical and performance characteristics and intended User Profile are included in the Accompanying document随机文件包括医疗器械、工作原理、重要的物理和性能特性和预期用户的特征的简要描述。The Accompanying docu
33、ment is written at a level consistent with the intended operator profile随机文件的编写要与用户特征的水平相一致。The Accompanying document for equipment are, optionally, provided electronically设备的随机文件或者可以电子文件提供。Usability engineering process includes the information that will need to be provided as a hard copy or as mark
34、ings on Medical Device when accompanying documents are provided electronically当随机文件是电子形式时,可用性工程过程应包括在医疗器械上需要以硬拷贝或标识提供的信息。7TRAINING AND MATERIALS FOR TRAINING/培训和培训材料The required training on the medical device for safe and effective use of primary operating functions by the intended User is given by:
35、 由预期用户安全有效使用医疗器械主要操作功能的必须培训包括: necessary training materials provided by the manufacturer;制造商提供的必要的培训材料; necessary training materials are available; or必要培训材料的可获得性; the manufacturer provides training或制造商提供培训The Accompanying document describes the available training options (Recommendation: accompanyin
36、g document include the suggested duration and frequency of such training) 随机文件要描述可获得的培训选项(推荐:随机文件包括此类培训时间和频度的建议)Intended use and user profile(s) are the basis for training and training material预期用途和用户特征是培训和培训材料的基础。List of documents make up the UE file组成可用性工程文档的文件列表4.2Document title/文件题目Version/版本sup
37、plementary information/备注:- 高氯酸对阿胶进行湿法消化后, 用导数火焰原子吸收光谱技术测定阿胶中的铜、“中药三大宝, 人参、鹿茸和阿胶。”阿胶的药用已有两千多年的悠久历史, 历代宫 马作峰.论疲劳源于肝脏J.广西中医药,2008,31(1):31. 史丽萍,马东明, 解丽芳等.力竭性运动对小鼠肝脏超微结构及肝糖原、肌糖元含量的影响J. 辽宁中医杂志, 王辉武,吴行明,邓开蓉.内经“肝者罢极之本”的临床价值J . 成都中医药大学学报,1997,20(2):9. 杨维益,陈家旭,王天芳等.运动性疲劳与中医肝脏的关系J.北京中医药大学学报. 1996,19(1):8.1 运
38、动性疲劳与肝脏 张俊明.“高效强力饮”增强运动机能的临床J中国运动医学杂志,1989,8(2):10117 种水解蛋白氨基酸。总含量在56.73%82.03%。霍光华采用硝酸-硫酸消化法和18(4):372-374.1995,2062 林华,吕国枫,官德正等. 衰竭运动小鼠肝损伤的实验性J.天津体育学院党报, 1994,9(4):9-11. 凌家杰.肝与运动性疲劳关系浅谈J.湖南中医学院学报.2003,2(6)31. 凌家杰.肝与运动性疲劳关系浅谈J.湖南中医学院学报.2003,23(6):31. 谢敏豪等.训练结合用中药补剂强力宝对小鼠游泳耐力与肌肉和肝Gn, LDH 和MDH 的影响J中国
39、运动医学杂 杨维益,陈家旭,王天芳等.运动性疲劳与中医肝脏的关系J.北京中医药大学学报. 1996,19(1):8.2.1 中药复方2.2 单味药33 阿胶和复方阿胶浆 常世和等.参宝片对机体机能影响的J.中国运动医学杂志,1991,10(1):49. 聂晓莉,李晓勇等.慢性疲劳大鼠模型的建立及其对肝功能的影响J. 热带医学杂志,2007,7(4):323-325.3.1 概述3.2 关于阿胶和复方阿胶浆医疗保健作用的3.2.1 营养成分和评价3.2.2 阿胶的药理作用3.2.3 阿胶的临床应用4 Xie MH, etalEffects of Hong jing tian she 1u on
40、reproductive axis function and exercise capacities in men. The5 周志宏等补肾益元方对运动小鼠抗疲劳能力的影响J.中国运动医学杂志,2001,20(1):83-84202-204.5InternationalCourseandConferenceonPhysiologicalChemistry and Natrition of exercise and training (Abstract)6 杨维益等中药复方“体复康”对运动性疲劳大鼠血乳酸、p 一内啡肤、亮氨酸及强啡肤Al-13 影响的实验研。仙灵口服液可提高机体运动能力,加速运
41、动后血乳酸的消除。F3 口服液能调整PCO2 孙晓波等鹿茸精强壮作用的J.中药药理与临床,1987,3(3):11. 于庆海等高山红景天抗不良刺激的药理J中药药理与临床,1995,7(7):283. 牛锐淫羊藿炮制前后对小鼠血浆睾丸酮及附近性器官的影响J中国中药杂志,1989,14(9):18P 0.05) 。肝脏是动物机体重要脏器之一,Pi,同疲),肝主筋,人之运动皆由于筋,故为罢极之本”。人体肝脏的功能活动也必阿胶, 味甘性平, 入肺、肝、肾经, 具有补血止血、滋阴润肺的功效。神农本阿胶,又称驴皮胶,为马科动物驴的皮去毛后熬制而成的胶块,是中国医药宝库中阿胶、熟地配伍能使补而不滋腻, 共奏
42、益气补血之功, 主要治疗各种原因导致的气血阿胶对细有促进作用;提示阿胶能提高机体免疫功能。 另外阿胶具阿胶具有很好的止血作用,常用来治疗阴虚火旺、血脉受伤造成的出血。比如,阿胶能治疗缺铁性贫血,再生障碍性贫血等贫血症状,阿胶对血小板减少,白细阿胶是一类明胶蛋白,经水解分离得到多种氨基酸,阿胶具有很多的药理作用和阿胶又称驴皮胶, 为马科动物驴的皮去毛后熬制而成的胶块。中药界有句口头禅:阿胶中的营养成分比较多,主要有蛋白质、多肽、氨基酸、金属元素、硫酸皮肤。把阿胶应用于运动员或人群中的实践应用性,具有很大的潜力和市场前景,白血病、鼻咽癌、食道癌、肺癌、乳腺癌等。阿胶不温不燥,老少皆宜,一年四季均伴
43、随现代竞技体育的强度越来越大,运动员在大运动量训练后出现的各种疲劳征象,胞减少等症也具有效果明显效果;另外,经配伍,阿胶可用来治疗多种出血症。医学保健作用,阿胶具有耐缺氧、耐寒冷、抗疲劳和增强免疫功能作用;同时,阿胶具有本文的目的意义有以下两个方面:一是通过阿胶的抗疲劳能力,来进一本以运动性疲劳相关症状明显的篮球运动员为对象,以谷丙转氨酶、谷表明,阿胶还用于治疗妊娠期胎动不安,先兆流产,习惯性流产等。对于月经病步了解运动员服用阿胶以后,不但能够使男女运动员的谷草转氨酶含量水平、谷丙转参促进人体对糖原和三磷酸腺苷等能源物质的合理利用, 并使剧烈运动时产生的乳草经将其列为上品。本草纲目载阿胶“疗吐
44、血衄血, 血淋尿血, 肠风下痢, 女草转氨酶、谷酰转肽酶、总胆红素、白蛋白和白蛋白/球蛋白含量水平为测定指标,产生运动。从中医学的观点来看,筋就是聚集在一起的肌肉束,膜是筋的延长和扩布;常所说的肌腱和韧带等器官,韧带和肌腱坚韧有力。通过韧带和肌腱伸缩牵拉骨骼肌充在筋”, 也就说明了筋的功能受到肝脏的调节, 所以, 医家大多从筋与肝相关的角除运动后的疲劳, 已经成为运动医学领域的热点,而中医药在改善、消除运动性促进肌肉和肝脏有氧氧化能力的作用。 红景天圣露能促进机体运动后的恢复和消除促进血液凝固和抗贫血作用,有提高血红蛋白红细胞,白细胞和血小板的作用。到影响。的变化, 主要表现为部分肝细胞破裂,
45、 内容物进入窦状隙, 未受损的肝细胞糖原明的核心问题之一, 也是运动训练学所要克服的核心问题之一, 疲劳是机体的一的滋补类药品;因始产于聊城东阿,故名阿胶,距今已有两千多年的生产历史;最早低分子肽含量分别是15%45%、10.97%13.18% 。霍光华采用标准水解法和氨基低运动后血清尿素氮含量; 加速体内尿素氮及血乳酸的清除速率;提高小鼠的游泳点、“肝之合筋”的观点、“肝者,其充在筋” 的观点、“食气入胃,散精于肝,淫气于动领域的广泛应用。动性疲劳关系最为密切者当首推肝脏。动性疲劳后机体恢复作用和机制的十分活跃。动员和贮备,以及机体对运动刺激的适应和运动后的疲劳的恢复起到重要的促进作用度阐述肝与疲劳的关系, 其实肝尚可通过脏腑气血等多个途径影响疲劳感的产生和度的DS 标准液, 加适量天青试液, 536nm 处测定吸收值, 建立工作曲线回归方程。对于运动产生的机理, 中医学解释比较通俗易懂, 即:韧带和肌腱的伸缩牵拉骨对运动性疲劳的多集中于中枢疲劳与外周肌肉疲劳,而较少涉及肝脏实质器而略于补立法,以健脾保肝、补中益气组方的确是防治运动性疲劳的一条新思新。故发挥和延缓运动性疲劳的产生都能起积极而有效的作用。总之,体力和
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