风险分析-ISO14971-2007.doc

Risk Analysis Report风 险 分 析 报 告公司名称：Company Name:公司地址：Company Address:产 品：Product:型 号：Model:附 件:Accessories:标 准：Standard:EN ISO 14971：2007结 论：Result:所有可识别的风险都已经被评估。在采取适当的措施以降低这些风险之后，关于产品预期的应用和用途上，各种等级的风险是可以接受的。All risks associated with the identified hazards have been evaluated. After appropriate measures to reduce these risks have been taken, the overall level of risk of the product is acceptable with regard to the intended application and use of the application.编写Compiled by:(Name/Title/Dept.)日期Date:评审Reviewed by(Name/Title/Dept.) 日期Date: 批准Approved by:(Name/Title/Dept.)日期Date:特征的定性定量分析： (acc. to ISO 14971:2007, Annex C.2)Identification of qualitative and quantitative characteristics (acc. to ISO 14971:2007, Annex C.2)以下条款，如果不适用就写NA，适用就写清楚条件，要用英文1预期用途和怎样使用：Intended use and how to use2是否植入设备：Is implanted?3是否接触病人或其他人：Intended to contact patient or other person4所用的元件/材料：Materials/components used5能量给予/源于病人：Energy to/from patient6物质给予/源于病人：Substances to /from patient7被加工的生物材料：Biological materials processed8灭菌/用户灭菌或其它微生物控制：Sterile/Intended to be sterilized9用户是否需日常清洁或消毒：routinely cleaned and disinfected by the user10改变病人环境：Modify patient environment11测量功能：Measurements12器械输出的数据解释：Interpretative13是否与其它药物或医疗技术联用：use in conjunction with medicines or other medical technologies14不需要的能量或物质输出：Unwanted outputs of energy or substances15受环境影响:（操作、运输的存储的环境，包括溢出，电能和冷却提供）Susceptible to environmental influences16器械是否影响环境influence the environment17基本消耗品/附件Consumables/accessories associated18是否需要维护或校正Routine maintenance/calibration19是否包括软件Software20是否有严格的寿命周期Restricted “shelf-life”:21延长/长期使用的影响Delayed and/or long-term use effect22使用者或病人对器械机械力控制Mechanical forces 23决定器械的寿命（包括老化）Lifetime of the device determined 24一次性/重复使用Single use/re-use25是否需安全退出运行或处置safe decommissioning or disposal26安装和使用是否需特殊培训Special training required to install or use27如何提供安全使用的信息Information for safe use28新生产过程是否需建立或引入new manufacturing processes need to be established or introduced29是否器械的成功使用，决定性的取决于人为因素，如用户接口successful application of the medical device critically dependent on human factors, such as user interface29.1用户界面的特征能导致使用错误User interface design features contribute to use error29.2是否在能因分心导致错误的环境中使用Used in distraction environment29.3医疗器械是否有连接部分或附件connecting parts or accessories29.4是否有控制接口control interface29.5器械是否显示信息display information29.6器械是否由莱单控制controlled by a menu29.7是否由特殊人士使用Used by persons with special needs29.8是否通过用户界面来开始(控制)动作Initiate user actions30器械是否提供警报系统Alarm system31故意的误用Deliberately misused32器械是否持有患者的关键数据Data critical to patient care?33器械是否可移动或可携带式To be mobile or portable34器械的使用是否依赖基本性能 Depend on essential performance?Letters in the first column refer to ISO 14971:2007, Annex C.2其它重要的特征以下的条款不适用也是NA，适用的要写清楚条件。page 15 of 16Risk Analysis公司Company：产品Products ：No.危害Hazards风险评估Risk Evaluation减低风险措施Risk Reduction Measure证明EvidenceNHALOR总论 General详细说明可能的危害Identify hazardsSODRLD2. Energy Hazards 能量危害1电能 Electricity2热 Heat3机械力 Mechanical force4离子辐射 Ionizing radiation5非离子辐射 Non-ionizing radiation6电磁场 Electromagnetic fields7可移动部件 Moving parts8悬浮物 Suspended masses9支持病人器械失败 Patient support device failure10压力(管壁破裂) Pressure(vessel rupture)11声压Acoustic pressure12振动 Vibration13磁场 Magnetic fields(e.g. MRI)D3. Biological hazards 生物危害1微生物污染 Bio-contamination2生物不相容 Bio-incompatibility3不正确的成份(化学组成) Incorrect formulation(chemical composition)4毒性 Toxicity5变态反应性allergenicity6诱变性mutagenicity7致瘤性oncogenicity8致畸性teratogenicity9致癌性Carcinogenicity10再感染，交叉感染Re-and/or cross-infection11致热性pyrogenicity12不能保持卫生安全Inability to maintain hygienic safety13降解 DegradationD4. Environmental hazards and contributory factors 环境危害及其形成因素1电磁场electromagnetic fields2不充足的能量或冷却提供 Inadequate supply of power or coolant 3对电磁干扰的敏感性Susceptibility to electromagnetic interference4电磁干扰的发射Emissions of electromagnetic interference5不充足的能量提供 Inadequate supply of power6不充足的冷却提供inadequate supply of coolant7储存或操作偏离规定的外部环境条件Storage or operation outside prescribed environmental conditions8与其它器械不相容 Incompatibility with other devices9意外的机械危害 Accidental mechanical damage10废弃物和/或器械处置的污染 Contamination due to waste products and /or device disposalD5. Hazards resulting from incorrect output of energy and substances 不正确的能量和物质输出产生的危害1电能electricity2辐射radiation3音量volume4压力pressure5医疗气体的供应supply of medical gases6麻醉剂的供应supply of anaesthetic agentsD6. Hazards related to the use of the device and contributory factors使用器械危害及其形成因素1不适当的标签 Inadequate labeling2不适当的使用手册Inadequate operating instructions如： 附件技术规范不适当inadequate specification of accessories 预使用检查规范不适当inadequate specification of pre-use checks 操作说明书过于复杂over-complicated operating instructions 服务和维修规范不适当inadequate specification of service and maintenance3由无经验或未经培训的人使用 Use by unskilled/untrained personnel4合理的可预见的错误使用 Reasonably foreseeable misuse5不充分的副作用警告Insufficient warning of side effects6不充分的一次性使用器械重复使用后的可能危害 Inadequate warning of hazards likely with re-use of single use devices7不正确的测量和其它方面计量Incorrect measurement and other metrological aspects8与消耗品/附件/其它器械不相容 Incompatibility with consumables/accessories/other devices9锐边、锐角sharp edges or pointsC7. 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 errors2重叠和认知检索错误Lapses and cognitive recall errors3滑移和疏忽（精神或实际的）Slips and blunders (mental or physical)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 system6含糊的或不清晰的医疗器械状态Ambiguous or unclear device state7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 information8结果的错误呈显示Mispresentation of results9视觉、听觉或触觉的不充分Insufficient visibility, audibility or tactility10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 state11与现存设备相比，模式或图象成问题Controversial modes or mappings as compared to existing equipmentD8. 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 transfer2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 checks3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 integrity6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 re-use and / or Improper re-use8由于重复使用使用造成的功能恶化（如液/气路的逐渐闭塞、流阻、电导率的变化）Deterioration in function (e.g. gradual occlusion of fluid/gas path, or change in resistance to flow, electrical conductivity) as a result of repeated use.B2. Additional hazards to in vitro diagnostic medical devices 体外诊断医疗器械的额外危害1批次的不均匀性、批次和批次的不一致性Batch inhomogeneity, batch-to-batch inconsistency2共同的干扰因素Common interfering factors3延期效应Carry-over effects4样本标示错误Specimen identification errors5稳定性问题（在储存中、运输中、使用中、容器第一次打开后）Stability problems (in storage, in shipping, in use, after first opening of the container)6与样本的抽取、准备及稳定性问题Problems related to taking, preparation and stability of speciments7先决条件的不适当技术规范Inadequate specification of prerequisites8不适当的试验特性）Inadequate test characteristics生产后信息Post-production information生产后经验Post-production experience:风险管理经验的评审Review of risk management experience:缩略词：Abbreviations usedRE风险评估Risk EvaluationS严重程度Severity (10 非常严重very severe, 1 不严重 not severe)O发生频率Occurrence (10 经常often, 1 不发生never)D可发现Detection (10 当风险发生时不可能发现impossible to detect before risk occurs, 1 当风险发生时一定可发现will be certainly detected before risk occurs)RL风险等级Risk Level = 严重性Severity 发生频率Occurrence 可发现Detection 1-9: 可忽略的风险，不需进一步行动 neglectable risk, no further actions; 9-24: 中等风险，建议预防措施 moderate: minimal risk, preventive action recommended; 25-48: 中等风险，要求预防措施 moderate risk, preventive action required; 48: 风险通常一般不可接受 risk is usually not acceptableRRM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评分标准（仅供参考）：EffectSEVERITY of EffectRanking伤害客户或员工Injure a customer or employee10违反法律/法规Be illegal9使得产品的使用/维护不再适用Render product or service unfit for use8引起客户的极度不满Cause extreme customer dissatisfaction7导致局部故障Result in partial malfunction6产品性能下降, 引起客户抱怨Cause a loss of performance which is likely to result in a complaint5产品性能有很小的下降Cause minor performance loss4能够克服, 但令人讨厌Cause a minor nuisance but can be overcome with no performance loss3对产品性能有微小影响, 但不被关注Be unnoticed and have only minor effect on performance 2没有影响Be unnoticed and not affect the performance