EN62366-2008-医疗器械可用性工程评估报告.doc
《EN62366-2008-医疗器械可用性工程评估报告.doc》由会员分享,可在线阅读,更多相关《EN62366-2008-医疗器械可用性工程评估报告.doc(11页珍藏版)》请在咨信网上搜索。
1、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Product Name/产品名称Report Reference No/编号.:Version/版本号:验证人:Date of issue/发布日期:版本修改记录:日期版本说明验证人审批人4GENERAL REQUIREMENTS/总要求4.1General Requirements/总要求4.1.1Usability Engineering Process/可用性工程过程H
2、as the manufacturer established, 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?User Manual;Quality manual, procedure document;ComplianceDoes the Process
3、 address user interactions with the medical device according to the accompanying 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?User ManualCompliance4.1.2Are Residual Risks associated
4、 with Usability of the medical Device presumed to be acceptable, unless there is objective evidence 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?Risk analysis report ;Compliance4.1.3manufacturer shall subject the information for safety used as a risk control to the usability engineering proc
5、ess (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Risk analysis report ;User Manual;ComplianceDisregarding 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
6、用)Risk analysis report Compliance4.2The 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。Quality manual, procedure document;ComplianceThe records and other documents that make up the usability engineering file may form part of other docu
7、ments 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Quality manual, procedure documentCompliance4.3Scaling of the Usability Engineering effort/可用性工程的调整The usability engineering proce
8、ss 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Risk analysis report Compliance5USABILTY ENGINEERING PROCESS/可用性工程过程5.1Application specification/应用的规格Application of Medical Device in the usability engin
9、eering file is specified by 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;User ManualCompliance intended patient population (e.g., ag
10、e, weight, health, condition);预期患者群,如年龄、体重、健康和社会条件;User ManualCompliance 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;User ManualCompliance intended conditions of use (e.g. environment including hygienic requirements, frequency of use, location, mobility); a
11、nd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;User ManualCompliance operating principle(s)操作原理User ManualCompliance5.2Frequently used functions/常用功能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
12、户与医疗器械交互的常用功能?User ManualCompliance5.3Identification 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 characteristics to safety/识别安全特征Identification of characteristics related to safety (part of a risk analysis) that focuses on usability performed accord
13、ing 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Risk analysis report ComplianceDuring the identification characteristics related to safety, the following are considered: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
14、用功能。User ManualComplianceResults 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 User ManualCompliance5.3.2Identification of known or foreseeable hazards and hazardous situations/识别已知的或可预见的危害和危害处境manufacturer has identified know
15、n 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Risk analysis report ComplianceIdentification of hazards considered hazards to patients, users and other persons 识别危害时要考虑对患者、操作者和其他人员的危害Risk analysis
16、report ComplianceReasonably 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次序和组合已经被识别。导致的可
17、能的危害的严重程度已确定。Risk analysis report ComplianceDuring 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 HAZARD
18、S and HAZARDOUS 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 re
19、sulting in a HAZARDOUS 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。Risk analysis report User ManualComplianceThe 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
20、和严重程度的结果要记录在可用性工程文档里。Risk analysis report Compliance5.4Primary operating functions/主要操作功能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。User ManualComplianceThe inputs to the primary operating functions include
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- EN62366 2008 医疗器械 可用性 工程 评估 报告
1、咨信平台为文档C2C交易模式,即用户上传的文档直接被用户下载,收益归上传人(含作者)所有;本站仅是提供信息存储空间和展示预览,仅对用户上传内容的表现方式做保护处理,对上载内容不做任何修改或编辑。所展示的作品文档包括内容和图片全部来源于网络用户和作者上传投稿,我们不确定上传用户享有完全著作权,根据《信息网络传播权保护条例》,如果侵犯了您的版权、权益或隐私,请联系我们,核实后会尽快下架及时删除,并可随时和客服了解处理情况,尊重保护知识产权我们共同努力。
2、文档的总页数、文档格式和文档大小以系统显示为准(内容中显示的页数不一定正确),网站客服只以系统显示的页数、文件格式、文档大小作为仲裁依据,个别因单元格分列造成显示页码不一将协商解决,平台无法对文档的真实性、完整性、权威性、准确性、专业性及其观点立场做任何保证或承诺,下载前须认真查看,确认无误后再购买,务必慎重购买;若有违法违纪将进行移交司法处理,若涉侵权平台将进行基本处罚并下架。
3、本站所有内容均由用户上传,付费前请自行鉴别,如您付费,意味着您已接受本站规则且自行承担风险,本站不进行额外附加服务,虚拟产品一经售出概不退款(未进行购买下载可退充值款),文档一经付费(服务费)、不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
4、如你看到网页展示的文档有www.zixin.com.cn水印,是因预览和防盗链等技术需要对页面进行转换压缩成图而已,我们并不对上传的文档进行任何编辑或修改,文档下载后都不会有水印标识(原文档上传前个别存留的除外),下载后原文更清晰;试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓;PPT和DOC文档可被视为“模板”,允许上传人保留章节、目录结构的情况下删减部份的内容;PDF文档不管是原文档转换或图片扫描而得,本站不作要求视为允许,下载前自行私信或留言给上传者【精***】。
5、本文档所展示的图片、画像、字体、音乐的版权可能需版权方额外授权,请谨慎使用;网站提供的党政主题相关内容(国旗、国徽、党徽--等)目的在于配合国家政策宣传,仅限个人学习分享使用,禁止用于任何广告和商用目的。
6、文档遇到问题,请及时私信或留言给本站上传会员【精***】,需本站解决可联系【 微信客服】、【 QQ客服】,若有其他问题请点击或扫码反馈【 服务填表】;文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“【 版权申诉】”(推荐),意见反馈和侵权处理邮箱:1219186828@qq.com;也可以拔打客服电话:4008-655-100;投诉/维权电话:4009-655-100。