中兴 ISO 13485-2016 质量管理体系QP-17风险分析和管理控制程序

1、 12/31文件类别和属性上层文件质量手册文件属性程序文件模块属性风险管理维护部门研发部文件编号QP-12版 本A/0风险管理控制程序拟制审核批准日期日期日期文 件 修 订 履 历修订状态修订内容概述修订人批准人修订日期发至综合部采购部市场部研发部质量部生产部由:综合部目的为了对风险分析提供规定和指导，使所有产品的安全性和预期用途的适宜性判断有据可循，使产品的风险和安全性处于受控状态。范围本程序适用于本公司生产的医疗器械产品的风险分析和管理。定义 伤害：对健康和财产的实际损害和破坏。危害：伤害的潜在源。风险：一个导致伤害的发生概率及伤害的严重程度。风险分析：用以判定危害并估计风险的可得资料研究

2、。权责研发部：负责对产品全过程中的各关键阶段进行风险分析，形成风险分析报告。质量部：对关键风险点辅助研发部通过检验试验进行验证和控制。其它部门：必要时参与产品风险分析。风险管理的程序 确定项目风险管理小组研发工程师根据项目的特点确定风险管理小组成员,必须包括熟悉产品原理及功能的成员（如设计工程师），熟悉产品制造的成员，以及熟悉产品的应用的成员（如医师或临床专家），以及法规工程师,经研发工程部经理评审通过后填写在风险管理报告中。风险管理计划建立 研发工程师对每一类医疗器械产品建立风险管理计划以研发工程部经理审核后实施，如果相似产品使用同一份计划时，应说明其适宜性。 该计划至少应包括： 策划的风险

3、管理活动范围: 判定和描述医疗器械和适用于计划每个要素的生命周期阶段；职责和权限的分配；风险管理活动的评审与验证要求； 基于制造商决定可接受风险方针的风险可接受性准则，包括在损害发生概率不能估计时的可接受风险的准则；相关的生产和生产后信息的收集和评审的有关活动。 如果在医疗器械寿命周期内计划有变更，变更的记录应保持在相应风险管理文档中。风险分析 风险管理小组按照风险管理计划要求，采用DFMEA 和PFMEA对医疗器械在寿命周期的各个阶段所存在的风险及水平进行分析，风险分析结果应作为设计和开发输入，并在对设计和开发输入阶段对此进行评审。 风险管理小组根据医疗器械的预期用途、预期目的及任何合理的可

4、预见的误用，将其可能影响医疗器械的安全性的定性和定量特征列出清单，并规定期限度。根据分析结果，风险管理小组编写正常和故障与医疗器械有关的已知和可预见危害清单并加以识别，其中对危害处境中产生的事件可预见性后果记录在风险管理报告中。风险评价对每个已判定的危害，风险管理小组应评价其风险水平，并根据风险管理的计划中规定的准则，决定所估计的一个或多个风险是否低至不能再降低程度，在进行“5.5.3 ”风险和受益分析后，当判定需要降低风险时需要及时采取措施进行风险控制以使相关的直至风险可接受。风险控制风险控制方案分析、实施、验证风险管理小组对相应的风险进行分析，以使其把风险降低到可接受的水平。风险控制是一个

5、综合方法，其中可以考虑：通过设计取得适宜的稳定的安全性、针对医疗器械本身或在生产过程中应采取的防护措施、在产品包装上、Label或说明书告知安全信息等。研发工程部组织对所实施的风险控制措施的有效性进行验证，并将验证过程和结果记录在风险管理报告中，同时适当更新相关的DMR文档。剩余风险评价：风险管理小组应根据风险计划中规定的准则评价采取风险控制措施后存在任何的剩余风险，并记录在风险管理报告中。如果剩余风险不可接受则依5.5.1执行；若可接受则在风险管理报告中说明。风险与受益分析剩余风险经评价不可接受，而进一步采取风险控制措施又不实际，风险管理小组收集医疗器械的预期用途、预期目的等受益的资料和文献

6、，判断受益是否超过剩余风险，若超过则依5.5.4执行，若不超过则依5.5.1执行。产生的其他危害：风险管理小组在实施风险控制措施时应对其进行评价，以判定是否引入其他危害，如果引入则依按5.4 执行。若不引入则实施措施。全部剩余风险的评价：所有的风险控制措施已实施并验证后，风险管理小组应根据风险管理计划的中准则对由医疗器械造成的所有剩余风险进行评价，若可接受或受益超过风险则相应的DMR文档中体现，若不可接受则放弃该项目。并将全部剩余风险的评价结果记录在风险管理报告中。生产后信息质量法规部根据生产过程中、售后客户反馈的信息依不合格品控制程序及客户抱怨控制程序评价是否需要启动风险管理，若需要则反馈给

7、研发工程部依5.1-5.6执行，并更新相关的风险管理的文档。风险管理档案研发工程部应对每一类产品建立一个完整的风险管理档案，并随着医疗器械寿命周期内反馈的信息不断更新。该档案包括了医疗器械寿命周期各阶段涉及到风险管理的文件与录。并依文件与资料控制程序执行。 7 附件附件一 风险管理程序流程图附件二 由医疗器械引起的可能危害及其形成因素举例附件三 三区域风险图 记录风险管理报告 QR-QP-17-01风险管理计划 QR-QP-17-02附件二由医疗器械引起的可能危害及其形成因素举例1总则：本附件27给出有不同医疗器械引起的可能危害及其形成因素的不完全清单，这些清单的意图是提供一个风险分析程序中所

8、给判定可能危害的备忘录。2能量危害：包括以下内容：电能；热能；机械力；电离辐射；非电离辐射;运动部件;非预期的运动悬挂的质量；患者支持器械失效;压力（容量破裂）；声压；振动；磁场（如MRI磁共振成像仪）。3生物学危害：包括以下内容：生物污染；生物不兼容性；不正确的配方（化学成分）；毒性；变态反应性;突变性;致畸性；致癌性；再感染和/或交叉感染；热源；不能保持卫生安全性；降解。4环境危害：包括以下内容：电磁场；对电磁干扰的敏感性;电磁干扰的发射;不适当的能量供应;不适当的冷却剂供应;储存或运行偏离预定的环境条件；和其它预期使用的医疗器械的不兼容性;意外的机械破坏；由于废物和/或医疗器械处置的污染

9、。5由不正确的能量和物质输出所产生的危害包括以下内容：电能;辐射;音量;压力;医疗气体的供应;麻醉剂的供应。6. 与医疗器械使用有关的危害和形成因素 包括以下内容 不恰当的标记；不适当的操作说明如和医疗器械一起附件规范不恰当使用前检查规范不恰当操作说明书过于复杂服务和维护规范不恰当；由不熟练/未经培训的人员使用；合理地可预见的误用；对副作用的警告不充分；对一次性使用医疗器械可能重复使用的危害警告不适当；不正确的测量和其它计量方面的问题；与消耗品/附件/其它器械的不兼容性;锐边或锐尖。7. 不适当不合适或过于复杂的使用者接口(人/机交流) 包括以下内容 错误或判断错误;失误和认知检索错误;疏忽和

10、出错(精神的和或身体的);违反或缩减说明书程序等;复杂或混淆的控制系统;含糊的或不清晰的医疗器械状态;设置测量或其它信息的含糊或不清晰的显示;结果的错误再显示;视觉听觉或触觉的不充分;动作控制或实际状态信息显示的图象不清;与现有设备相比引起争议的模式或图象。 8.功能失效、维护及老化引起的危害和形成因素：包括以下内容：错误的数据转换;维护规范缺少或不恰当包括维修后功能性检查规范的不恰当;维护的不适当;对医疗器械寿命终止缺少适当的决定;电气/机械整合的丧失;不适当的包装(医疗器械的污染和/或变质);再次使用和/或不适当的再次使用;由重复使用造成的功能恶化(例如液/气路的逐渐闭塞流阻电导率的变化)

11、。(附件三)附件三 三区域风险图危害程度 1234概率等级6灰黑黑黑5灰灰黑黑4灰灰灰黑3白灰灰灰2白白灰灰1白白白注黑字区域风险不容许区 灰字区域风险广泛可接受区。不能作为不必要风险的可接受理由考虑到接受风险的受益和进一步降低的可行性任何风险都应降到可行的最低水平。 白字区域风险合理可行区产品定量分析表A.2.1预期用途/预期目的A.2.2是否预期和病人或其它人员接触A.2.3包含何种材料和/或组分或与其共同使用A.2.4是否有能量给予患者或从患者身上获取A.2.5是否有物质提供给患者或从患者身上提取A.2.6是否由医疗器械处理生物材料然后再次使用A.2.7是否以无菌或准备由使用者灭菌A.2

12、.8是否预期由用户进行常规清洁与消毒A.2.9是否预期改善患者的环境A.2.10是否进行测量A.2.11是否进行分析处理A.2.12是否预期和医药或其它医疗技朮联合使用A.2.13是否有不希望的能量或物质输出A.2.14是否对环境影响敏感A.2.15是否影响环境A.2.16是否有基本消耗品或附件A.2.17是否需要维护和校准A.2.18是否有软件A.2.19是否有储存寿命限制A.2.20是否有延迟和/或长期使用效应A.2.21承受何种机械力A.2.22是什幺决定医疗器械的寿命A.2.23是否预期一次性使用A.2.24是否需要安全的退出运行或处置A.2.25器械的安装或使用是否需要专门的训练A.

13、2.26是否需要建立或引入新的生产过程A.2.271器械是否有连接部分或附件A.2.27.2器械是否有控制接口A.2.27.3是否显示信息A.2.27.4是否由菜单控制A.2.28器械是否预期为移动式或便携式FOR-17-01A(附表二)危害级数分类表编号严重度(S)描述举 例1不明显发生伤害的可能很小或没有2轻 度发生较多伤害3严 重发生重伤4极其严重造成人员死亡/严重伤害FOR-17-02A(附表三)风险概率等级表编 号发生概率(O)描 述举 例1几乎不可能从未发生过2非常少典型的情况是，整个使用寿命周期内仅发生一次3很少典型的情况是，一千次使用中仅发生一次4偶然典型的情况是，一百次使用中

14、可能发生一次5有时典型的情况是，十次使用中有发生一次6经常典型的情况是，每次使用中都有发生一起.FOR-17-03A产品风险分析及控制措施表No.危害风险评估降低风险措施表现采取措施后的风险评估是否产生新的风险概括描述SORLSORL 123456备注 S 危害等级 O 风险概率 RL风险水平(即风险水平=危害等级风险概率) DOCPROPERTY 文件编号 * MERGEFORMAT 错误！未知的文档属性名称（ DOCPROPERTY 版本 * MERGEFORMAT 错误！未知的文档属性名称）第 PAGE 2 页 共 NUMPAGES 25 页Risk management report

15、Page PAGE 31 of NUMPAGES 31 Risk management report Page PAGE 29 of NUMPAGES 31 风险管理计划QR-QP-17-01 RevA0、背景2、适用范围3、职责与权限3.1 项目组组长3.1.1负责风险管理人员的安排，担任风险管理组组长。3.1.2负责组织风险管理各项活动的进行。3.1.3评审与批准风险管理等相关的报告3.2 风险管理评审人员3.2.1 产品法规工程师：负责评审中关注是否符合法规和标准的要求3.2.1产品临床工程师：负责评审中关注产品是否符合临床的要求。3.2.3 产品测试工程师：负责评审与验证风险管理活动中

16、的安规测评。3.2.4 产品设计工程师：负责识别医疗器械在整个寿命周期中的风险。3.2.5结构工程师：负责根据识别出产品结构方面在应用中存在风险。3.2.6专家：负责根据医疗器械的预期用途，从产品的工作原理与临床应用中全面的提出相应的风险，并评估。4、风险接受性准则4.1 概率分级分级发生概率（频次/年）6 频繁15 很可能1 1014 偶然10-1 10-23 很少10-2 10-42 几乎不可能10-4 10-61 难以置信10-6严重度分级分级含义1可忽略的（几乎没有或没有潜在伤害的可能）2极轻度的（潜在轻度伤害的可能）3严重的（潜在致伤致残的可能）4灾难的（潜在的致死的可能）风险可接受

17、性准则概率损害的严重度1可忽略的2极轻度的3严重的4灾难的6 频繁ALARPNACCNACCNACC5 很可能ALARPALARPNACCNACC4 偶然ALARPALARPALARPNACC3 很少ACCALARPALARPALARP2 几乎不可能ACCACCALARPALARP1 难以置信ACCACCACCACC备注:ACC：可接受的风险；ALARP：合理可行降低的风险；NACC：不经过风险/收益分析即判定为不可接受的风险。5、风险管理活动计划产品生命周期阶段风险管理过程计划时间责任人备注市场调研类似产品上市后，临床应用中存在的风险政府当局的不良事件数据将此阶的风险纳入在立项报告中可行性分

18、析、评审（根据预期目的）设计开发策划初始风险分析（包括初始特征判定、危害判定和初始风险控制方案分析）根据14971的标准进行设计输入整理前风险的相关资料组织评审形成初步的风险管理报告设计输入阶段评审和风险管理评审一并进行设计开发实施风险控制措施在设计开发中查核是否有遗漏的风险没有识别可结合设计阶段性验证的同时验证风险控制有效性设计输出1、进一步验证风险控制措施的有效性设计评审风险管理评审分析完整性评价完善风险管理文档设计评审和风险管理评审一并进行设计验证样品评审、验证验证风险控制措施的有效性及实际落实情况风险管理评审整理前一阶段的风险管理过程记录，完善风险管理文档过程确认样品试产风险管理评审，

19、整理前一阶段的风险管理过程记录，完善风险管理文档设计确认临床试验、临床资料评价风险/受益分析综合剩余风险评价风险管理评审，完善风险管理文档整理DMR和DHF/包括风险管理文档试产识别试产中存在的风险更新风险管理报告产品注册申报上市风险管理评审，评审结果形成风险管理报告量产按不合格品控制程序、数据分析程序、纠正措施/预防措施控制程序实施产品生产过程中的风险管理生产后阶段按信息反馈控制程序实施生产后阶段的风险管理CONFIDENTIALDocument No.: Version: XXDevelopment Document QR-QP-17-02 RevA0Total Pages: XXXPro

20、ject name:XXXX SUBJECT * MERGEFORMAT Document name:Risk management reportWritten: Auditor: Approved: Date:Date:Date:Revision RecordVer.Revision descriptionReviserDateTable of Contents TOC o 1-3 h z HYPERLINK l _Toc375898757 Table of Contents PAGEREF _Toc375898757 h 2 HYPERLINK l _Toc375898758 Chapte

21、r1 Summary PAGEREF _Toc375898758 h 3 HYPERLINK l _Toc375898759 Chapter2 Risk Analysis Participants PAGEREF _Toc375898759 h 4 HYPERLINK l _Toc375898760 Chapter3 General Introduction PAGEREF _Toc375898760 h 5 HYPERLINK l _Toc375898761 3.1Category PAGEREF _Toc375898761 h 5 HYPERLINK l _Toc375898762 3.2

22、Product Overview PAGEREF _Toc375898762 h 5 HYPERLINK l _Toc375898763 3.3Intended Use PAGEREF _Toc375898763 h 5 HYPERLINK l _Toc375898764 3.4Composition PAGEREF _Toc375898764 h 5 HYPERLINK l _Toc375898765 3.5Relative standard PAGEREF _Toc375898765 h 5 HYPERLINK l _Toc375898766 Chapter4 Judgment of Ch

23、aracteristics Rate to Safety PAGEREF _Toc375898766 h 6 HYPERLINK l _Toc375898767 Chapter5 Summarization of the Risk Management PAGEREF _Toc375898767 h 10 HYPERLINK l _Toc375898768 Chapter6 Information of Production and Post-Production PAGEREF _Toc375898768 h 12 HYPERLINK l _Toc375898769 Chapter7 Com

24、pleteness Evaluation of Risk PAGEREF _Toc375898769 h 13 HYPERLINK l _Toc375898770 Chapter8 Evaluation of Residual Risk PAGEREF _Toc375898770 h 14 HYPERLINK l _Toc375898771 Chapter9 Information updating and risk management after manufacturing PAGEREF _Toc375898771 h 15 HYPERLINK l _Toc375898772 Appen

25、dix A. Analysis method PAGEREF _Toc375898772 h 16 HYPERLINK l _Toc375898773 A.1Harm analysis method PAGEREF _Toc375898773 h 16 HYPERLINK l _Toc375898774 A.2Risk estimate method PAGEREF _Toc375898774 h 16 HYPERLINK l _Toc375898775 Appendix B. Analysis Method PAGEREF _Toc375898775 h 17 HYPERLINK l _To

26、c375898776 B.1. Estimation of the severity of each hazard PAGEREF _Toc375898776 h 17 HYPERLINK l _Toc375898777 B.2. Estimation of the likelihood of each hazard PAGEREF _Toc375898777 h 18 HYPERLINK l _Toc375898778 B.3. Estimation of the acceptability of each risk PAGEREF _Toc375898778 h 19 HYPERLINK

27、l _Toc375898779 Appendix C Abbreviations used PAGEREF _Toc375898779 h 20 HYPERLINK l _Toc375898780 Appendix D Contents of Tables PAGEREF _Toc375898780 h 21SummaryStandard informationStandardISO14971: 2007NameMedical devices - Application of risk management to medical devicesTest product informationN

28、ameModelConclusionFail itemRemarkRisk Analysis ParticipantsMemberDepartmentPositionResponsibilitySignatureDirectorResearch and development departmentTechnology managerBe responsible for planning, approval and application of risk management report.-MemberResearch and development departmentManagerAnti

29、cipate the activities of planning, writing, evaluation and application of risk management report.Research and development departmentEngineerProvide information and experiences from the viewpoint of technology;Anticipate the activities of risk analysis and review;Review the activities of risk managem

30、ent；Provide risk control methods in the viewpoint of technology.Manufacture departmentManagerProvide information and experiences from the viewpoint of manufacturing;Anticipate the activities of risk analysis and review;Review the activities of risk management;Provide risk control methods in the view

31、point of manufacturing.Market departmentManagerProvide information and experiences from the viewpoint of product control, sale and after sale service;Anticipate the activities of risk analysis and review;Review the activities of risk management;Provide risk control methods in the viewpoint of produc

32、t control, sale and after sale service.Quality departmentQuality directorAnticipate the activities of risk analysis and review;Verification the effect of risk management methods.Quality departmentTest operator(When necessary) test product.General IntroductionCategoryThis document is established acco

33、rding to standard ISO14971:2007-the risk management for medical devices. The goal is to systematically carry out the effective management of the various risk processes for the companys R&D and manufacture of XXXXX The document is the instructive direction for design, confirmation, production and sal

34、es, and for CE authentication, FDA authentication and SFDA authentication constituent.Product OverviewIntended UseCompositionRelative standardStandard TypeNumberNameNoteRisk ManagementISO14971:2007Medical devices - Application of risk management to medical devicesCENUSABio-compatibilityEN ISO10993-1

35、:2009Biological evaluation of medical devices - Part1: Evaluation and testingCENSafetyIEC 60601-1:2005Medical electrical equipment - Part1: General requirements for basic safety and essential performanceCENEN 12470-4:2000+ A1:2009Clinical thermometers - Part 4: Performance of electrical thermometers

36、 for continuous measurementCENEMCEN 60601-1-2:2007Medical equipment - Part1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirements and testsCENUsabilityIEC60601-1-6:2006Medical electrical equipment Part 1-6:General requirements for basic safety and essenti

37、al performance Collateral Standard: UsabilityCENLabelEN 980:2008Graphical symbols for use in the labeling of medical devicesCENJudgment of Characteristics Rate to SafetyTable SEQ 表 * ARABIC 1 Qualitative and quantitative analysis of the characteristicsNoSafety-related characteristics that could have

38、 impact on safetyYes/NoSafety-related characteristics identification1What is the intended use and how is the medical device to be used?2Is the medical device intended to be implanted?3Is the medical device intended to contact the patient or other persons?4What materials or components are incorporate

39、d in the medical device or are used with, or are in contact with, the medical device?5Is energy delivered to or extracted from the patient?6Are substances delivered to or extracted from the patient?7Are biological materials processed by the medical device for subsequent re-use, transfusion or transp

40、lantation?8Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?9Is the medical device intended to be routinely cleaned or disinfected by the user?10Is the medical device intended to modify the patient environment?11Are mea

41、surements taken?12Is the medical device interpretative?13Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?14Are there unwanted outputs of energy or substances?15Is the medical device susceptible to environmental influences?16Do

42、es the medical device influence the environment?17Are there essential consumables or accessories associated with the medical device?18Is maintenance or calibration necessary?19Does the medical device contain software?20Does the medical device have a restricted shelf-life?21Are there any delayed or l

43、ong-term use effects?e.g., ergonomics and accumulative effects.22To what mechanical forces will the medical device be subjected?23What determines the lifetime of the medical device?24Is the medical device intended for single use?25Is safe decommissioning or disposal of the medical device necessary?2

44、6Does installation or use of the medical device require special training?27How will information for safe use be provided?28Will new manufacturing processes need to be established or introduced?29Is successful application of the medical device critically dependent on human factors such as the user in

45、terface?29.1Can the user interface design features contribute to use error?29.2Is the medical device used in an environment where distractions can cause use error?29.3Does the medical device have connecting parts or accessories?29.4Does the medical device have a control interface?29.5Does the medica

46、l device display information?29.6Is the medical device controlled by a menu?29.7Will the medical device be used by persons with special needs?29.8Can the user interface be used to initiate user actions?30Does the medical device use an alarm system?31In what way(s) might the medical device be deliber

47、ately misused?32Does the medical device hold data critical to patient care?33Is the medical device intended to be mobile or portable?34Does the use of the medical device depend on essential performance?Summarization of the Risk ManagementTable SEQ 表 * ARABIC 2 Summarization of the Risk ManagementIte

48、mPotential HazardsS(F/B)L（F/B）R（F/B）Risk Reduction MeasureVerificationCompanion new hazardALOR1Energy hazards1.12Biological hazards2.13Environmental hazards3.14.Incorrect outputs of energy and materials (NA)5.Hazards related to the use of the medical device5.16Hazards arising from inadequate, inappr

49、opriate or over-complex user interfaces (human/machine communication)6.17Hazards arising from functional lack, maintenance failure and ageing7.18Inaccurate output data8.1Information of Production and Post-ProductionItemInformation of Production and Post-ProductionS(F/B)L（F/B）R（F/B）MeasureVerificatio

50、nCompanion new hazardALORCompleteness Evaluation of RiskAll known or foreseeable hazards have been analyzed.Evaluation of Residual RiskAfter the above analysis and carrying out corresponding risk control measures, the residual risks of the potential hazards associated with the use of the device acco

51、rding to the intended use are acceptable. The device has passed the tests required by the harmonized standards, which also proves that risks associated with the device are acceptable.The risk control measures have not introduced any new hazards. After all risk control measures have been implemented

52、and verified, there are no ALARP or N/ACC risks, so the risk/benefit analysis is not necessary.Information updating and risk management after manufacturingWe will collect and update the information from producing client complaining, similarity design and so on, and then according the “medical device

53、 risk management procedure review and manage the information ItemUpdating informationS（F/BL（F/B）R（F/B）Control measurevalidationNHALORAppendix A. Analysis methodHarm analysis methodReasonable may foresee situationThe harm involves objectHarm initial reasonConsideration questionWhen analysis the harms

54、, must consider reasonable may foresee situation, including: Under regular service condition; Under un-regular service conditionsIf is suitable, the harm analysis should include: Regarding patients harm; Regarding operators harm; Regarding servicemans harm; Regarding nearby personnels harm; Regardin

55、g environment harm.If is suitable, the harm initial reason should include: Human factor including man-machine engineering limit; Hardware breakdown; Software breakdown; Comprehensive mistake; Environmental condition.If is suitable, considered the question includes: System part compatibility, includi

56、ng hardware and software; User interface, including instruction language, warning and error message; In user interface and instruction for use language translation accuracy; Prevented the human intends or has no intention behavior data protection measure; Risk/Profiting criterion; Third party softwa

57、re.Risk estimate methodThe risk estimate of out body diagnoses instrument - - Analysis result confidence level; - - Specious inspection; - - Comparison usability and use; - - Is suitable for the medical laboratory quality assurance measure/Method; - - Flaw/Wrong detect ability; - - Service condition

58、 (for example emergency case); - - Specialist/Laymans use;- - The method provides informationAppendix B. Analysis MethodB.1. Estimation of the severity of each hazardTable SEQ 表 * ARABIC 3 Estimating severity of each hazardLevelSeverityInjury to humanHazard to diagnostic or treatment informationHaza

59、rd to the equipmentHazard to environment4catastrophicDeath, severe physical functional disorder or mental derangement and all kinds of serious injury requiring cares. Serious destroy of environment3Critical Physical functional disorder or mental derangement, which leads to difficulty of normal life

60、or requires hospitalization.Radiation exposure exceeding the limits stipulated by ICRP (1990).Improper treatment or hospitalization caused by misdiagnosis. Explosive breakdown. Energy emission or dropping with fatal power.Building catches fire. Contamination of hazardous material2Marginal Temporary