ISO14971-2007风险管理报告模板_中英对照

RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 1 of 19 Written By: 作者 Reviewed By: 审核 REV. ECN History ECN 历史记录 Date 日期 APPROVALS 批准 APPROVAL 批准批准 NAME 名称名称 FUNCTION 功能功能 SIGNATURE 签名签名 DATE 日期日期 Director of Engineering 工程主管 Operations Manager 业务经理 Project Engineer 项目工程师 PRODUCTS:产品：产品： Product Name 产品名称产品名称 Model No. 型号型号 Engineering No. 工程设计编号工程设计编号 RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 2 of 19 Table of Contents 目录目录 TABLE-E.1 ENERGY HAZARDS 表格 E-1 兼容危害性.4 ELECTROMAGNETIC ENERGY 电磁兼容性.4 RADIATION ENERGY 辐射电磁波.4 MECHANICAL ENERGY 机械兼容性.4 TABLE-E.1 BIOLOGICAL AND CHEMICAL HAZARDS 表格 E-1 生化危害性.5 BIOLOGICAL 生物学制品.5 CHEMICAL 化学制品.5 BIOCOMPATABILITY .6 TABLE-E.1 OPERATIONAL HAZARDS 表格 E-1 操作危害性.6 FUNCTION 功能.6 USE ERROR 使用误差.7 TABLE-E.1 INFOMATION HAZARDS 表格 E-1.7 LABELING 标号.7 OPERATATING INSTRUCTIONS 操作使用说明.8 WARNINGS 警告.8 TABLE-E.2 INITIATING EVENTS AND CIRCUMSTANCES 表格 E-2 启动结果与环境.9 INCOMPLETE REQUIREMENTS:不完全.9 MANUFACTURING PROCESSES 生产程序 .9 TRANSPORT AND STORAGE 运输和储存.10 ENVIROMANTAL FACTORS 环境因素.10 CLEANING, DISENFECTING, AND STERIALIZATION.10 DISPOSAL AND SCRAPPING 处理和报废.11 FORMULATION 简要表述 .11 HUMAN FACTORS 人为因素 .12 FAILURE MODES 故障模式.13 Conclusion:结论.14 To be completed per instructions SOP-XX-XXRisk Management, current revision, in conjunction with standard ISO 14971 and MDD 93/42/EEC 对于完成的标准操作程序中的风险管理和近期修正中的每项说明都应与 标准的ISO 14971 以及 MDD 93/42/EEC 保持一致 Note: ALL Boxes in matrix must have an entry whether applicable or not. 注：所有的方框, 必须要做登记适用与否 (Use N/A for boxes which are not applicable, The ACTION TAKEN Box must be filled out for an explanation “Why it is not Applicable”) （使用 N/A 来判定方框哪个是不适用的。采用的方框必须填写明确的解释，“为什么不能用”） RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 3 of 19 PROBABILITY OF OCCURRENCE 发生的发生的 可能性可能性 PROBABILITY RANGE 概率等级概率等级 DESCRIPTION 描述描述 FREQUENT 发生频率发生频率 10-3OCCURRING OFTEN OR REPEATEDLY 经常发生或反复发生 PROBABLE 很可能的很可能的 10-3 and 10-4REASONABLY LIKELY TO OCCUR 有时候可能发生 OCCASIONAL 偶发的偶发的 10-4 and 10-5IRREGULAR OCCURRENCE, INFREQUENT 不规律发生， 不常见的 REMOTE 很少发生的很少发生的 10-5 and 10-6NOT LIKELY TO OCCUR 不可能发生 IMPROBABLE 不可能的不可能的 10-6 UNLIKELY TO EVER OCCUR 不大可能发生 SEVERITY 严重程度严重程度 DESCRIPTION 描述描述 CATASTROPHIC 致命的致命的 RESULTS IN PATIENT DEATH 导致患者死亡 CRITICAL 危险的危险的 RESULTS IN PERMANENT IMPAIRMENT OR LIFE-THREATENING INJURY 导致永久性损伤或危及生命的伤害 SERIOUS 严重的严重的 RESULTS IN INJURY OR IMPAIRMENT REQUIRING PROFESSIONAL MEDICAL INTERVENTION 导致伤害或需要医务人员介入 MINOR 次要的次要的 LOW RISK FAILURE NOT EXPECTED TO CONTRIBUTE TO AN INJURY 比较低的风险故障对之造成的伤害不可预知 NEGLIGIBLE 微小的微小的 INSIGNIFICANT FAILURE NOT SERIOUS ENOUGH TO CONTRIBUTE TO AN INJURY 可以忽略的故障不足以促成严重伤害 RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 4 of 19 SEVERITY CATEGORIES 严重程度分类严重程度分类 PROBABILITY OF OCCURRENCE 发生的可能性发生的可能性 NEGLIGIBLE 忽略不计忽略不计 MINOR 次要次要 SERIOUS 严重严重 CRITICAL 危险临界危险临界 CATASTROPHIC 致命致命 FREQUENT 频率频率 147531 PROBABLE 可能可能 169752 OCCASIONAL 偶发偶发 1812964 REMOTE 很少很少 191513118 IMPROBABLE 不可能不可能 2017151310 HAZARD RISK INDEX 危险指数危险指数 ACCEPTANCE CRITERIA 接受标准接受标准 1 TO 5UNACCEPTABLE 不能接受 6 TO 9UNDESIRABLE. WRITTEN & REVIEWED DECISION TO PROCEED 著明不合格或需要进一步审核 10 TO 16ACCEPTABLE UPON COMPLETION OF QUALITY 可接受的在质量达标上线 ASSURANCE/REGULATORY REVIEW 保险但要调制审核 17 TO 20ACCEPTABLE WITHOUT REVIEW 合格不需要审查 RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 5 of 19 Examples of hazards, foreseeable sequences of events and hazardous situations from EN ISO 14971:2007 Annex E 危险的例子, 可预测事情进展以及危险情况 TABLE-E.1 ENERGY HAZARDS电磁波危害电磁波危害 ELECTROMAGNETIC ENERGY电磁兼容性电磁兼容性 HAZARD 危害因素危害因素 APPLICABLE 适用的适用的 POTENTIAL FAILURE 潜在故障潜在故障 CAUSE OF FAILURE 故障原因故障原因 EFFECTS OF FAILURE 故障影响故障影响 RESPONSE 反应反应 RISK INDEX 危险指数危险指数 ACTION TAKEN 采用的措施采用的措施 Line Voltage 线路电压 Yes No Design 设计 Label 标签 Enclosure Leakage current 附件漏电 Yes No Design Label Earth Leakage current 接地漏电 Yes No Design Label Patient Leakage current 耐漏电 Yes No Design Label Electric Fields 电场 Yes No Design Label Magnetic Fields 磁场 Yes No Design Label RADIATION ENERGY电磁波辐射电磁波辐射 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSE RISK INDEX ACTION TAKEN Ionizing radiation 致电离辐射 Yes No Design Label Non-ionizing radiation 非电离辐射 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 6 of 19 MECHANICAL ENERGY HAZARDAPPLICABLE POTENTIAL FAILUR CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Gravity - Falling 地心引力-下落 Yes No Design Label Gravity suspended masses 地心引力被悬浮 的质量 Yes No Design Label Vibration 振动 Yes No Design Label Stored Energy 储存的能量 Yes No Design Label Moving Parts 移动的部件 Yes No Design Label Torsion, shear and tensile force Yes No Design Label Moving and positioning of patient 患者移动和转动 Yes No Design Label Acoustic energy - ultrasonic energy 声能-超声波能 量 Yes No Design Label Acoustic energy - infrasound energy 超低声波能 Yes No Design Label Acoustic energy - sound 声音 Yes No Design Label High pressure fluid injection 高压液体注入 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 7 of 19 TABLE-E.1 BIOLOGICAL AND CHEMICAL HAZARDS生物化学危害生物化学危害 BIOLOGICAL生物学的生物学的 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSE RISK INDEX ACTION TAKEN Bacteria 细菌 Yes No Design Label Viruses 病毒 Yes No Design Label Other agents (e.g. prions) 其它 Yes No Design Label Re- or cross- infection 交差感染 Yes No Design Label CHEMICAL: Exposure of airway, tissues, environment or property e.g. to foreign materials 化学因素：导气管暴露、组织、环境、外来材料化学因素：导气管暴露、组织、环境、外来材料 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Acids or alkalis 酸碱 Yes No Design Label Residues 残留物 Yes No Design Label Contaminants 污染物 Yes No Design Label Addictives or processing aids 加工助剂 Yes No Design Label Cleaning, disinfecting or testing agents 清洁消毒或检测 制剂 Yes No Design Label Degradation products 降解产物 Yes No Design Label Medical gasses 医疗气体 Yes No Design Label Anesthetic products 麻醉制剂 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 8 of 19 BIOCOMPATABILITY, Toxicity of chemical constituents, e.g.化学毒性成分化学毒性成分 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Allergenicity/ irritancy 过敏性/刺激 Yes No Design Label Pyrogenicity (induce fever) 发热性( 导致发 烧) Yes No Design Label TABLE-E.1 OPERATIONAL HAZARDS操作危害操作危害 FUNCTION功能功能 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Incorrect or inappropriate output or functionality 不正确或不适当 的输出或功能性 Yes No Design Label Incorrect measurement 不正确测量 Yes No Design Label Erroneous data transfer 错误资料传递 Yes No Design Label Loss or deterioration of function 功能丧失或恶化 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 9 of 19 USE ERROR 使用错误使用错误 HAZARD APPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Attentional failure 保养不当 Yes No Design Label Memory failure 记忆故障 Yes No Design Label Rule-based failure 设立基准规则故 障 Yes No Design Label Knowledge- based failure 系统故障 Yes No Design Label Routine Violation 违反常规 Yes No Design Label TABLE-E.1 INFOMATION HAZARDS 信息危害信息危害 LABELING标签标签 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Incomplete instructions for use 不完全按照使用 说明书操作 Yes No Design Label Inadequate description of performance characteristics 不完整的工作特 性说明书 Yes No Design Label Inadequate specification of accessories to be used with the medical device Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 10 of 19 用于医疗器械的 附件说明书不完 整 Inadequate disclosure of limitations 有限的改进但不 完整 Yes No Design Label OPERATATING INSTRUCTIONS操作说明操作说明 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Inadequate specification of accessories to be used with the medical device 用于医疗器械的 附件说明书不完 整 Yes No Design Label Inadequate specification of pre-use checks 预先使用 Yes No Design Label Over- complicated operating instructions 过于复杂的操作 说明书 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 11 of 19 WARNINGS警告警告 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Warnings of side effects 副作用的警告 Yes No Design Label Warnings of hazards likely with re-use of single-use medical devices 危险警示可能与 单纯重复使用医 疗设备有关 Yes No Design Label SPECIFICATION OF SERVICE AND MAINTENANCE维护保养说明维护保养说明 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Inadequate specification of when service and maintenance is required 当需要维护保养 时，说明书不详 尽 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 12 of 19 TABLE-E.2 INITIATING EVENTS AND CIRCUMSTANCES启动结果启动结果 INCOMPLETE REQUIREMENTS, Inadequate Specification of:不完全要求，不完全要求， 不充分的说明：不充分的说明： HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Design parameters 设计参数 Yes No Design Label Operating parameters 操作参数 Yes No Design Label Performance requirements 性能要求 Yes No Design Label In-service requirements (e.g. maintenance, reprocessing) 运行中要求（维 护，重复处理） Yes No Design Label End of life 保质期结束 Yes No Design Label MANUFACTURING PROCESSES, Insufficient control of:产品处理程序，产品处理程序， 没有完全控制没有完全控制: HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Changes to manufacturing process 改变产品的程序 Yes No Design Label Materials / materials compatibility information 材料兼容性报告 Yes No Design Label Manufacturing processes 生产程序 Yes No Design Label Subcontractors 次承包商 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 13 of 19 TRANSPORT AND STORAGE运输和储存运输和储存 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Inadequate packaging 不适当包装 Yes No Design Label Contamination or deterioration 污染或变质 Yes No Design Label Inappropriate environmental conditions 不良的环境条件 Yes No Design Label ENVIROMANTAL FACTORS环境因素环境因素 HAZARDAPPLICABLEPOTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Physical (e.g. heat, pressure, time) 物理上的（热， 压力，时间） Yes No Design Label Chemical (e.g. cocorrosions, degradation, contamination)化 学上的（腐蚀， 变质，污染） Yes No Design Label Electromagnetic fields (e.g. susceptibility to electromagnetic disturbance) 电磁场（易受电 磁干扰） Yes No Design Label Inadequate supply of power 能量不能充分供 应 Yes No Design Label Inadequate Yes Design RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 14 of 19 supply of coolant 冷却剂不能充分 供应 No Label CLEANING, DISENFECTING, AND STERIALIZATION HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Lack of, or inadequate specification for, validated procedures for cleaning, disinfecting and sterilization. 缺乏或对有效性 没有充分的说明， 对清洁消毒杀菌 过程没有充分说 明 Yes No Design Label Inadequate conduct for cleaning, disinfecting and sterilization 没有对清洁消毒 杀菌进行充分的 指导 Yes No Design Label DISPOSAL AND SCRAPPING处理和报废处理和报废 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN No, or inadequate information provided. 提供不准确的信 息 Yes No Design Label Use error 使用误差 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 15 of 19 FORMULATION明确地表达明确地表达 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Biodegration Yes No Design Label Biocompatibility 生物适应性 Yes No Design Label No Information or inadequate specification provided 没有提供信息或 充分说明 Yes No Design Label Inadequate warnings of hazards associated with incorrect formulations 不充分的危险警 告与不正确的表 达 Yes No Design Label Use error 使用误差 Yes No Design Label HUMAN FACTORS, Potential for use errors triggered by design flaws, such as:人为因素，设计缺陷而引起可能使用误差人为因素，设计缺陷而引起可能使用误差 HAZARDAPPLICABLE POTENTIAL FAILURE CAUSE OF FAILURE EFFECTS OF FAILURE RESPONSERISK INDEX ACTION TAKEN Confusing or missing instructions for use 使用说明书使用 不当或丢失 Yes No Design Label Complex or confusing control system 复杂或混乱的控 制系统 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 16 of 19 Ambiguous or unclear device state 含混不清的设计 说明 Yes No Design Label Ambiguous or unclear presentation of settings, measurements or other information 设置说明，尺寸 或其它介绍含混 不清 Yes No Design Label Misrepresentation of results 结果误 报 Yes No Design Label Insufficient visibility, audibility of tactility 触感的可见度， 可听度不够 Yes No Design Label Poor mapping of controls to actions, or of displayed information to actual state 对具体的情态信 息显示，对动作 的控制影象都很 差 Yes No Design Label Controversial modes or mapping as compared to existing equipment 与现有的装置相 比，模式和影象 Yes No Design Label RISK MANAGEMENT REPORT NO. RM-(PROJECT #)-00X Sheet 17 of 19 都有争议 Use by unskilled/untrain ed personnel 设备由不熟练和 没有培训过的人 员来操控 Yes No Design Label Insufficient warnings of side effects 副作用的 警告不够完备 Yes No Design Label Inadequate warnings of hazards associated with re-use of single- use medical devices 不适当的警告拌 有单一反复使用 医疗设备 Yes No Design Label Incorrect measurement and other metrological aspects. 不正确的尺