Risk Analysis+manufacturing process

1、Risk Analysis公司名称Company:桂林中辉科技发展有限公司产品名称Product:自动尿液分析仪Risk Management风 险 管 理公司名称：Company Name:桂林中辉科技发展有限公司公司地址：Company Address:桂林市西城经济开发区鲁山工业区产 品：Product:自动尿液分析仪型 号：Model:ZH60附 件:Accessories:标 准：Standard:ISO 14971:2000 /A1:2003 Medical Devices-Application of Risk Management of Medical DevicesGHTF

2、SG3/N15R8 (May 2005) Implementaion of Risk Management Principles and Activities within a Quality Management System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 r

3、isks have been taken, the overall level of risk of the product and processes is acceptable with regard to the intended application and use of the application.编写Compiled by:(Name/Title/Dept.)林珏瑾日期Date:2005/12/15评审Reviewed by(Name/Title/Dept.) 李学军日期Date: 2005/12/16批准Approved by:(Name/Title/Dept.)姚崇德日期

4、Date:2005/12/17特征的定性定量分析： (acc. to ISO 14971:2000, cl. 4.2)Identification of qualitative and quantitative characteristics (acc. to ISO 14971:2000, cl. 4.2)1预期用途和怎样使用：Intended use and how to use普及型尿常规分析。适合在大医院的科室、专科医院、社区医疗站、流动或救护医疗车、私人诊所、学校卫生室使用。2是否接触病人或其他人：Intended to contact patient or other person

5、否，本产品为体外诊断仪器，不与人体发生接触。3所用的元件/材料：Materials/components used主机、试纸托板、电源适配器。4能量给予/源于病人：Energy to/from patient否，本产品无能量给予/源于病人。5物质给予/源于病人：Substances to /from patient是，本产品检测的样本为源于病人的尿液。6被加工的生物材料：Biological materials processed否，本产品无被加工的生物材料。7灭菌/用户灭菌或其它微生物控制：Sterile/Intended to be sterilized否，本产品无需灭菌操作。8用户是否需

6、日常清洁或消毒：routinely cleaned and disinfected by the user是，用户需日常清洁。9改变病人环境：Modify patient environment否，本产品为体外诊断仪器，不与人体发生接触。10测量功能：Measurements是，定量测量尿液中的生化物质。11器械输出的数据解释：Interpretative是，产品说明书有解释。12是否与其它药物或医疗技术联用：use in conjunction with medicines or other medical technologies是，本产品与本公司生产的尿分析试纸条配合使用。13不需要的能

7、量或物质输出：Unwanted outputs of energy or substances否，本产品的能量只用于打印机和试纸托板传动工作。14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 influences是，潮湿的空气和腐蚀性气体对仪器造成损害。避免日光直接照射。在25±4环境下使用。使用过程中应避免频繁开关电源开关，关机和开机间隔应在5秒以上。15器械是否影响环境influence the environment16基本消耗品/附件Consumables/accessories associated

8、是，本产品与本公司生产的尿分析试纸条配合使用。17是否需要维护或校正Routine maintenance/calibration是，本产品应进行日常维护。18是否包括软件Software是，本产品使用了软件。19是否有严格的寿命周期Restricted “shelf-life”:是，主机5至10年，储电池2至3年。20延长/长期使用的影响Delayed and/or long-term use effect是，检测数据不准确。21使用者或病人对器械机械力控制Mechanical forces 否，本产品的使用者无需对产品施加任何力。22决定器械的寿命（包括老化）Lifetime of the

9、 device determined 是，主机5至10年，储电池2至3年。23一次性/重复使用Single use/re-use是，本产品可以重复使用。24是否需安全退出运行或处置safe decommissioning or disposal是，本产品使用完毕应按操作要求退出运行。25安装和使用是否需特殊培训Special training required to install or use是，本产品的安装和使用应经过培训。26新生产过程是否需建立或引入new manufacturing processes need to be established or introduced是，本产品

10、是本公司的新产品，已建立了新的生产线。27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 interface是，器械的成功使用取决于使用者按使用说明书的要求进行操作。27.1医疗器械是否有连接部分或附件connecting parts or accessories是，本产品有外接电源和试纸条托槽。27.2是否有控制接口control interface是，本产品有USB接口。27.3器械是否显示信

11、息display information是，本产品可通过屏幕显示或打印机打印检测结果。27.4器械是否由莱单控制controlled by a menu是，本产品的使用由菜单控制。28器械是否可移动或可携带式To be mobile or portable是，本产品为便携式。Letters in the first column refer to ISO 14971:2000, cl. 4.2.其它重要的特征page 46 of 16Risk Analysis公司Company：桂林中辉科技发展有限公司产品Products ：自动尿液分析仪No.危害Hard风险评估Risk Evaluatio

12、n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 Heat否，本产品不产生热能。0001无产品说明书无可3机械力 Mechanical force是，本产品产生机械力只用于传送尿液分析试纸条。0901无产品说明书无可4离子辐射 Ionizing radiation否，本产品不产生离子辐射。0001无产品说明书无可5非离子辐射 Non-ionizing radiation否，本产品不产生非离子辐射

13、。0001无产品说明书无可6电磁场 Electromagnetic fields是，本产品产生微弱电磁场。0901无产品说明书无可7可移动部件 Moving parts是，本产品有一个试纸托板和电源适配器。0901无产品说明书无可8悬浮物 Suspended masses否，本产品没有悬浮物。0001无产品说明书无可9支持病人器械失败 Patient support device failure否，本产品不与人体发生接触。0001无产品说明书无可10压力(管壁破裂) Pressure(vessel rupture)否，本产品不产生压力。0001无产品说明书无可11声压Acoustic pres

14、sure是，打印机打印及试纸托板传动时有轻微声音。0901无产品说明书无可12振动 Vibration是，打印机打印及试纸托板传动时有轻微振动。0901无产品说明书无可13磁场 Magnetic fields(e.g. MRI)是，本产品产生微弱磁场。0901无产品说明书无可D3. Biological hazards 生物危害1微生物污染 Bio-contamination否，本产品不产生微生物。2生物不相容 Bio-incompatibility否，本产品不与人体发生接触。3不正确的成份(化学组成) Incorrect formulation(chemical composition)否，

15、本产品使用的物质都经过验证。4毒性 Toxicity否，本产品没有任何毒性。5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-infection否，本产品不与人体发生接触。11致热性pyrogenicity否，本产品不产生热量。12不能保持卫生安全Inability to maintain hygienic safety否，本产品不产生污染物。13降解 Degradation否，本产品没有生物降解的物质。D4. Env

16、ironmental hazards and contributory factors 环境危害及其形成因素1电磁场electromagnetic fields是，符合GB/T 182682000中I组B类设备的要求。2不充足的能量或冷却提供 Inadequate supply of power or coolant 是，本产品产生的能量只用于打印机打印及试纸托板传动。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

17、 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 devices是，本产品需与本公司生产的尿分析试纸条配合使用。9意外的机械危害 Accidental mechanical damage否，本产品不会对人体产生机械危害。10废弃物和/或器械处置的污染 Contamination due

18、 to waste products and /or device disposal否，本产品可重复使用不产生废弃物。D5. 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

19、 and contributory factors使用器械危害及其形成因素1不适当的标签 Inadequate labeling否，本产品标签严格按98/79/EC附录I 8.4的要求进行编制。2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 in

20、structions§ 服务和维修规范不适当inadequate specification of service and maintenance否，本产品说明书严格按98/79/EC附录I 8.7的要求进行编制。否，本产品配有全面解释的说明书，无需另配技术参数说明。否，本产品使用前按说明要求使用本公司生产的尿分析试纸条即可。否，本产品配有全面解释的说明书，但简单扼要，使操作非常容易。3由无经验或未经培训的人使用 Use by unskilled/untrained personnel否，本产品应由有经验或经过培训的人使用。4合理的可预见的错误使用 Reasonably forese

21、eable misuse否，本产品由有经验或经过培训的人使用，只要按说明书的要求进行操作就不易错误。5不充分的副作用警告Insufficient warning of side effects否，本产品不与人体接触，不会对人体产生副作用。6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 devices否，本产品可重复使用。7不正确的测量和其它方面计量Incorrect measurement and other metrological aspects否，本产品由专业人员按

22、说明书的要求进行操作，都能得出测量结果。8与消耗品/附件/其它器械不相容 Incompatibility with consumables/accessories/other devices否，本产品只与本公司生产的尿分析试纸条配合使用。9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 error

23、s2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 u

24、nclear presentation of settings, measurements or other information8结果的错误呈显示Mispresentation of results否，只要按照产品说明书的要求使用本产品，都能得出正确测量结果。9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

25、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 transfer否，只要按照产品说明书的要求使用本产品，都能得出正确测量结果。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 main

26、tenance including inadequate specification of post maintenance functional checks否，本仪器只需按产品说明书的要求进行日常维护。3不适当的维护 Inadequate maintenance 否，本仪器只需按产品说明书的要求进行日常维护。4缺乏决定器械寿命的因素决定Lack of adequate determination of end of device life 否，只要按产品说明书进行使用与维护就能达到器械寿命。5缺少电气/机械完整性 Loss of electrical / mechanical integr

27、ity否，本产品在出厂前已配齐配套附件。6不适当的包装(污染和/或器械损坏) Inadequate packaging(contamination and /or deterioration of the device )否，本产品已经过防潮、抗震、抗压的包装处理。7重复使用或不正确的重复使用 re-use and / or Improper re-use否，本产品由专业人员进行操作使用。8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 pat

28、h, or change in resistance to flow, electrical conductivity) as a result of repeated use.Hazards arising from Product Realization Processes外包 Outsourcing制造商可以外包生产过程 (如灭菌, 加工, 实验, 设计, 制造) 或产品(部件, 组件或 整个 产 品). 必须持续控制这些外包过程和产品。制造商负责整合这些过程和产品的风箱管理活动，其方法包括策划和风险控制措施。A manufacturer may outsource processes

29、(e.g. sterilization, tooling, coating processes, testing, design, manufacturing) or products (components, subassemblies or entire devices) and must maintain control over these outsourced processes and products. The manufacturer is responsible for incorporating appropriate risk management activities

30、for these processes and products by planning and by ensuring risk control measures are appropriately applied.外包过程或产品更改的批准和执行之前制造商必须保证:-更改的评审-评估新的风险是否业已被发现-确定现有或新的残留风险和或整个风险，根据已有的接受准则是否可以接受。Before the approval and implementation of a change to any outsourced process or product, the manufacturer shoul

31、d:· Review the change;· Assess if new risks have been discovered; and,· Determine if current and/or new individual residual risks and/or the overall risk isacceptable according to the predetermined existing acceptability criteria.如果对任何外包过程或产品采取风险控制措施，风险控制措施和其重要性应记录在采购资料或信息中，并清楚地传达给供应商

32、。If there are any risk control measures applied to outsourced process or products, the risk control measures and their importance should be documented within the purchasing data orinformation and clearly communicated to the supplier.策划 Planning风险管理策划需要覆盖医疗器械地整个生命周期。Risk management planning needs to

33、span the entire life cycle of a medical device. 设计与开发Design and Development风险管理应该在设计和开发的最初阶段开展，在问题出现之前进行预防要比问题出现之后再纠正更为容易。Risk management activities should begin as early as possible in the design and development phase, when it is easier to prevent problems rather than correcting them later. 对于每一个确定

34、的不利因素，其正常与非正常状态下的风险都应该被评估。For each identified hazard, the risk in both normal and fault conditions is estimated. 在风险评估的过程中，器械生产商应判定减低风险的必要性。评估的结果，例如风险控制手段的必要性，应作为设计输入的一部分。In risk evaluation, the manufacturer decides whether risk reduction is needed. The results from this risk evaluation such as the

35、need for risk control measures then become part of the design input.风险控制手段属于设计输出的一部分，在设计确认过程中应该进行评估。Risk control measures are part of the design output and are evaluated during design verification. 这种设计输出/输入确认循环应该贯穿于整个设计控制程序中，并反复进行。直到剩余风险被减少到可接受的水平而且能够维持在这一水平。This design input/ output/ verification

36、cycle will iterate and continue throughout the overall design control process until the residual risks have been reduced to an acceptable level and can be maintained at an acceptable level. 风险控制程序的总体有效性在设计确认过程中应该被证实。The overall effectiveness of risk control measures is confirmed during design valida

37、tion.器械投放市场后，风险管理行为应与质量管理程序结合。例如，生产和过程控制，纠正和预防措施，服务与顾客反馈。After release of the device to market, risk management activities should be linked to quality management processes, for example, production and process controls, corrective and preventive actions (CAPA), servicing and customer feedback.以风险控制为目

38、的的设计和开发行为应有相关文件支持。Design and development activities targeted at controlling risks should be supported by documentation. 这种文件应该将设计行为与确定的风险相关联，以证实设计控制本身及其范围与风险程度是合理的和适当的。This documentation should relate the design activities to identified risks in a way that provides objective evidence that the nature

39、 and extent of the design control is reasonable and appropriate to the degree of risk.设计与开发策划Design and Development Planning设计与开发策划应确保风险管理的一致性是来自于设计和开发过程。Design and development planning should ensure that coordination of risk management activities is conducted during design and development. 设计和开发策划应

40、确定-适当的风险管理行为和设计开发行为之间的内部关联；-所需要的资源，包括确保充分的潜在安全关注所需的适当的专家意见。Design and development planning should identify:· The inter-relationship(s) between appropriate risk management activities and design and development activities; and,· The needed resources, including appropriate expertise required

41、to ensure sufficient coverage of potential safety concerns.设计和开发输入Design and Development Input设计和开发输入包括对预期使用目的、功能、特点、安全和调整要求的正确考虑。Design and development inputs include adequate consideration of intended use and functional, performance, safety and regulatory requirements.风险控制手段是风险管理行为的输出之一，应该被包含在设计和开

42、发过程之中。Risk control measures are one output from risk management activities, which should feed into the design and development process.风险分析包括确定危险因素以及由于那些风险因素所导致的伤害。同时，应该对这些伤害发生的风险进行评估。Risk analysis consists of identifying hazards and the potential harms due to those hazards and estimating the risks o

43、f those harms occurring. 不利因素的确定应该从医疗器械的预期使用目的、特点及环境等方面进行考虑。Hazard identification starts with consideration of the medical devices intended use, its characteristics and its environment. 如果适用，应该对来自于普通类型器械生产后信息的风险相关数据进行分析。Risk-relateddata from post-production information for the generic type of device

44、 should be considered if it is available.另外，应对来自于器械制造方法中的风险相关信息进行分析。In addition, risk-related information on the manufacturing methods to be used in the production of the device should be considered. 这些结果通常在已知的和可预见的不利因素初步清单中。这些不利因素可以从相关标准或其他数据资源如警戒数据库、独立产品检测报告等处寻找。This normally results in a prelimin

45、ary list of known and foreseeable hazards. Such hazards may be found in relevant standards orother data sources such as vigilance databases, independent product test reports, etc.确定的不利因素有可能会造成若干种伤害；同样，一种伤害也有可能是由若干种不利因素造成的。伤害发生的可能性及其严重性应得到确认。The identified hazards may produce several harms, as well a

46、s, one harm may come from several hazards. The probability of occurrence of the harm and its severity need to be determined. 参照事先完成的接受准则对这些不利因素的风险进行评估，以确定是否需要风险控制。Risks from these hazards are estimated and evaluated against previously established acceptability criteria to determine whether risk cont

47、rols are needed.在实际执行之前，为了后续的安全和规定的性能，对已确定的设计特点、规格和/或风险控制手段及与目前的风险分析相关的不利因素的任何被提议的改变都必须被仔细地评估。Any proposed changes to identified design characteristics, specifications, and/or risk control measures and their associated hazards from the current risk analysis must be carefully evaluated with respect t

48、o continued safety and specified performance of the device before actual implementation.如果器械预期与其他医疗器械或仪器协同使用、共同安装或相互连接，则不但要评估单个器械的不利因素和风险控制手段，同时还要对系统或联合体的不利因素和风险控制手段进行评估。If the device is intended to be used in combination with, or installed with, or connected to another medical device or equipment,

49、then hazards and risk control measures should be evaluated for each device individually as well as the system or combination as a whole.进行设计和开发输入时，应考虑风险控制手段的必要性。When establishing design and development inputs, the need for risk control measures should be considered. 如果确定风险控制手段是必须的并已被初步确认，应该将其列为设计输出，

50、作为重复循环的一个部分。When risk control measures are determined to be necessary and are initially defined, these become an output as part of the iterative cycle.Design Output 设计输出设计输入中确认的风险控制手段必须被计划并整和到设计和开发输出当中。这些控制手段的可行性应当得到评估。Risk control measures identified during the input phase must be designed and incorporated into the design and development output. These risk control measures will have to be evaluated as to their feasibility.设计和开发输出通常有三种类型。第一种类型包括医疗器械的特性和规格，及其安全和正确使用所需的要素。第二种类型与采购、生产、操作、销售及服务的要求有关。第三种类型包括医疗器械接收标准。所有类型都可能包括安全和正确使用