Risk Management Report.doc

FRND-SOP-002-01-03 Page 4 of 17 / FRND-SOP-002-01-03 第 4 页 共 17 页 Risk Management Analysis EvaluationReportNo序号Questions Description问题描述Identify判定Conclusion Description结论描述公司FORM 表格Document No.文件号:FRND-SOP-002-01-03RISK MANAGEMENT ANALYSISEVALUATIONREPORT 风险管理分析、评价、报告Effective Date 生效日期:2011-07-28Page 页码：Page 1 of 17File No文档编号Finalization Date 定稿日期:Analysis and Evaluation ReportAssignment of Responsibility职责分工Position职务：Signature签名：Date日期：Draw Up 编制人:Project Leader 项目负责人:Participator 参与人:一 Risk management team风险管理团队Name 姓名Assignment of responsibility 职责和权限二 Product instruction 产品介绍Product name产品名称Product model or code产品型号或物料代码Intended use预期用途Main structure主要结构Main materials主要材料Work environment使用环境三 Risk evaluation criteria 风险评价准则(参考)Table 1 Example of five qualitative severity levels 表1-严重度5级举类Severity严重度Criteria description标准描述Ranking等级Catastrophic灾难性的Results in patient death导致患者死亡5Severe危重的Results in permanent impairment or life-threatening injury导致永久型损伤或危及生命的伤害4Critical 严重Results in injury or impairment requiring professional medical intervention导致要求专业医疗介入的伤害或损伤3Marginal轻度Results in temporary injury or impairment not requiring professional medical intervention导致不要求专业医疗介入的暂时伤害或损伤2Negligible可忽略Inconvenience or temporary discomfort不方便或暂时不适1Table 2 Example of semi-quantitative probability levels 表2 概率6级示类Probability levels可能性Criteria description标准描述Ranking等级Frequent经常10-16Probable有时10-25Occasional偶然10-2and 10-34Rare很少10-3and 10-43Remote非常少10-4and 10-62 Improbable极少10-61Table 3 Detection Classifications 表3 探测度5级示类 Detection levels探测度Criteria description标准描述Ranking等级Almost Certain几乎确定Almost certainly detect a potential cause/mechanism and subsequent failure mode几乎确定可探测到潜在失效原因机理和引发的失效模式1High高High chance detect a potential cause/mechanism and subsequent failure mode有高的可能性探测到潜在失效原因机理和引发的失效模式2Moderate中等Moderate chance detect a potential cause/mechanism and subsequent failure mode有中等的可能性探测到潜在失效原因机理和引发的失效模式3Low低Low chance detect a potential cause/mechanism and subsequent failure mode有低可能性探测到潜在失效原因机理和引发的失效模式4Remote极小Remote chance l detect a potential cause/mechanism and subsequent failure mode有极小的可能性探测到潜在失效原因机理和引发的失效模式5Table 4 Risk Matrix 表4 风险矩阵Accept rankingSeverity levels严重度Negligible可忽略Marginal轻度Critical严重Severe危重的Catastrophic灾难性的Probability levels可能性Frequent经常612182430Probable有时510152025Occasional偶然48121620Rare很少3691215Remote非常少246810 Improbable极少12345 Risk Acceptable description 风险接受描述Key图类RPN=严重度发生可能性探测度Unacceptable risk 不可接受风险(RPN12 & 严重度3 & 发生可能性4)必须采取措施Need to take action 需采取措施降低风险Acceptable risk可忽略的风险FRND-SOP-002-01-03 Page 7 of 17 / FRND-SOP-002-01-03 第 7 页 共 17 页 Risk Management Analysis EvaluationReportNo序号Questions Description问题描述Identify判定Conclusion Description结论描述四 Questions list to device characteristics 器械特性问题清单： (Acc. to EN ISO 14971:2009, Annex C) No序号Questions Description问题描述Identify判定Conclusion Description结论描述1What is the intended use and how is the medical device to be used?什么是预期用途/预期目的和怎样使用医疗器械?2Is the medical device intended to be implanted?医疗器械是否预期植入？3Is 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员接触？4What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?在医疗器械中利用何种材料或组分，或与医疗器械共同使用或与其接触？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 ？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？7Are biological materials processed by the medical device for subsequent re-use, transfusion or transplantation?医疗器械是否处理生物材料用于随后的再次使用、输液/血或移植？8Is the medical 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，或用其它微生物学控制方法灭菌？9Is the medical device intended to be routinely cleaned and disinfected by the user?医疗器械是否预期由用户进行常规清洁和消毒？10Is the medical device intended to modify the patient environment?医疗器械是否预期改善患者的环境？11Are measurements taken?是否进行测量？12Is the medical device interpretative?医疗器械是否进行分析处理？13Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?医疗器械是否预期和其它医疗器械、医药或其它医疗技术联合使用？14Are there unwanted outputs of energy or substances?是否有不希望的能量或物质输出？15Is the medical device susceptible to environmental influences?医疗器械是否对环境影响敏感？16Does the medical device influence the environment?医疗器械是否影响环境？17Are there essential consumables or accessories associated with the medical device?医疗器械是否有基本的消耗品或附件？18Is maintenance or calibration necessary? 是否需要维护和校准？19Does the medical device contain software?医疗器械是否有软件？20Does the medical device have a restricted shelf-life?医疗器械是否有储存寿命限制？21Are there any delayed or long-term use effects?是否有延时或长期使用效应？22To what mechanical forces will the medical device be subjected?医疗器械承受何种机械力？23What determines the lifetime of the medical device?什么决定医疗器械的寿命？24Is the medical device intended for single use?医疗器械是否预期一次性使用？25Is safe decommissioning or disposal of the medical device necessary?医疗器械是否需要安全地退出运行或处置？26Does installation or use of the medical device require special training or special skills?医疗器械的安装或使用是否要求专门的培训或专门的技能？27How will information for safe use be provided?如何提供安全使用信息？28Will new manufacturing processes need to be established or introduced?是否需要建立或引入新的制造过程？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，是否关键取决于人为因素，例如用户界面？29.1Can the user interface design features contribute to use error?用户界面设计特性是否可能促成使用错误？29.2Is the medical device used in an environment where distractions can cause use error?医疗器械是否在因分散注意力而导致使用错误的环境中使用？29.3Does the medical device have connecting parts or accessories?医疗器械是否有连接部分或附件？29.4Does the medical device have a control interface?医疗器械是否有控制接口？29.5Does the medical device display information?医疗器械是否显示信息？29.6Is the medical device controlled by a menu?医疗器械是否由菜单控制？29.7Will the medical device be used by persons with special needs?医疗器械是否由具有特殊需要的人使用？29.8Can the user interface be used to initiate user actions?用户界面能否用于启动使用者动作?30Does the medical device use an alarm system?医疗器械是否使用报警系统？31In what way(s) might the medical device be deliberately misused?医疗器械可能以什么方式被故意地误用？32Does the medical device hold data critical to patient care?医疗器械是否持有患者护理的关键数据？33Is the medical device intended to be mobile or portable?医疗器械是否预期为移动式或便携式？34Does the use of the medical device depend on essential performance?医疗器械的使用是否依赖于基本性能？五 Hazards, foreseeable sequences of events and hazardous situations AnalysisEvaluationControl 危害可预见的事件危害处境 分析评价控制： (Acc. to EN ISO 14971:2009, Annex E)缩略词：Abbreviations usedRE风险评估Risk EvaluationS严重性Severity O发生频率Occurrence D发现程度Detection RPN风险优先指数Risk Priority Number = 严重性Severity 发生频率Occurrence 发现程度Detection RRM风险减少措施 Risk Reduction MeasureNH新危害发生New hazard generated (no/ yes - if yes, 如不可接受，写出危害号码 then number of new hazard indicated)ALOR风险是否可接受 Acceptable Level of Risk (no/ yes)FRND-SOP-002-01-03 Page 17 of 17 / FRND-SOP-002-01-03 第 17 页 共 17 页 Risk Management Analysis EvaluationReportNo.序号危害Hard风险评估Risk Evaluation减低风险措施RRMRisk Reduction Measure证明EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLE.1 Energy Hazards 能量危害1Line voltage 网电源/2Leakage current 漏电流/3Electric fields电场 /4Magnetic fields 磁场/5Ionizing radiation电离辐射/6Non-ionizing radiation非电离辐射/7High temperature高温/8Low temperature低温 /9Gravity falling 坠落 /10Suspended masses悬挂物 /11Vibration 振动 /12贮存的能量Stored energy /13Moving parts运动零件 /14Torsion, shear and tensile force扭转力、剪切力和张力 /15Moving and positioning of patient患者的移动和定位 /16Ultrasonic energy超声能量/17Infrasound energy次声能量/18Sound 声音 /19High pressure fluid injection高压液体注射 /E.2 Biological and Chemical Hazards 生物和化学危害1Bacteria 细菌 /2Viruses病毒 /3Other agents (e.g. prions)其他介质/4Re- or cross-infection再次或交叉感染 /5Acids or alkalis酸或碱/6Residues 残留物 /7Contaminates污染物 /8additives orprocessing aids添加剂或加工助剂 /9cleaning, disinfecting or testing agent清洁剂、消毒剂或试验试剂 /10Degradation products降解产物 /11medical gasses医用气体 /12Anaesthetic products麻醉产品 /13Toxicity of chemicalConstituents 化学毒性/14生物不相容 Bio-incompatibility/15allergenicity变态反应性/16irritancy刺激 /17pyrogenicity致热原 /E.3 Environmental hazards and contributory factors 环境危害及其形成因素1电能electricity/2Pressure 压力/3辐射radiation/4音量volume/5Susceptibility to electromagnetic interference对电磁干扰的敏感性/6Emissions of electromagnetic interference电磁干扰的发射/7供 Inadequate supply of power不充足的能量提/8inadequate supply of coolant不充足的冷却提供/9Storage or operation outside prescribed environmental conditions储存或操作偏离规定的外部环境条件/10Incompatibility with other devices与其它器械不相容/11Accidental mechanical damage意外的机械危害/12corrosions腐蚀/13degradation,降解/14contamination污染/E.4. Hazards related to the use of the device and contributory factors使用器械危害及其形成因素1Inadequate labeling不充分的标签 /2Inadequate operating instructions不适当的使用手册如： inadequate specification of accessories附件技术规范不适当 inadequate specification of pre-use checks预期使用检查规范不适当 over-complicated operating instructions操作说明书过于复杂 inadequate specification of service and maintenance服务和维修规范不适当/3Use by unskilled/untrained personnel由无经验或未经培训的人使用/4Reasonably foreseeable misuse合理的可预见的错误使用 /5Insufficient warning of side effects不充分的副作用警告/6Inadequate warning of hazards likely with re-use of single use devices不充分的一次性使用器械重复使用后的可能危害 /7Incorrect measurement and other metrological aspects不正确的测量和其它方面计量/8Incompatibility with consumables/accessories/other devices与消耗品/附件/其它器械不相容/9sharp edges or points锐边、锐角/E.5 Inappropriate, inadequate or over-complicated user interface (man/machine communication) 不正确、不充分或过于复杂的用户介面 （人/机交流）1错误或判断错误Mistakes and judgement errors/2重叠和认知检索错误Lapses and cognitive recall errors/3Attentional failure缺乏注意力 /4违反或偏离说明书、程序等Violation or abbreviation of instructions, procedures, etc.,/5复杂或混淆的控制系统Complex or confusing control system/6含糊的或不清晰的医疗器械状态Ambiguous or unclear device state/7设置、测量或其它信息的含糊或不清晰的显示Ambiguous or unclear presentation of settings, measurements or other information/8结果的错误显示Mispresentation of results/9视觉、听觉或触觉的不充分Insufficient visibility, audibility or tactility/10动作控制或实际状态信息显示的图象不清Poor mapping of controls to action, or of displayed information to actual state/11与现存设备相比，模式或图象成问题Controversial modes or mappings as compared to existing equipment/E.6. Hazards arising from functional failure, maintenance and ageing 功能性失效，维护、老化的危害和形成因素1错误的数据转换Erroneous data transfer/2维护(包括维修后功能检查技术参数不足)的技术参数不足或缺乏Lack of , or inadequate specification for maintenance including inadequate specification of post maintenance functional checks/3不适当的维护 Inadequate maintenance /4缺乏决定器械寿命的因素决定Lack of adequate determination of end of device life /5缺少电气/机械完整性 Loss of electrical / mechanical integrity/6不适当的包装(污染和/或器械损坏) Inadequate packaging(contamination and /or deterioration of the device )/7重复使用或不正确的重复使用 r