【精品】IEC606011 2005第3版 风险管理简介

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1、1IEC 60601-1:2005 第第3 3版版风险管理风险管理_简介简介 BeijingDec. 2011 路学军路学军Mobile:135 8159 7318Email: TV Rheinland (China) Ltd.2IEC 60601-1IEC 60601-1第第3 3版对风险管理的要求版对风险管理的要求Contents/内容内容1. Risk management of 3rd Ed./2. Responsibility 职责职责3. RM tools 风险管理评估指南，风险管理结果检查表风险管理评估指南，风险管理结果检查表4. Suggested workflow to ev

2、aluate IEC 60601-1 3rd ed.建议的工作流程建议的工作流程5. Example for implementation and verification of risk management process举例：风险管理的执行和验证举例：风险管理的执行和验证3IEC 60601-1第3版对风险管理的要求第第3 3版与第版与第2 2版最主要的区别：版最主要的区别： 风险管理要求的导入，风险管理要求的导入， 1、科技的发展_原有标准不足以保证产品的安全； (新技术带来新风险，新风险需要相应的控制措施，原标准要求不 能保证应用了新技术的产品仍然是安全的。因此，要求标准跟 上科技的

3、发展)；2、原标准的充分性受到了质疑(仅关注基本安全)； (对于生命支持设备，与预期用途有关的基本性能（临床功能）的失效导 致的风险可能比着火、电击、机械等风险更严重)；3、法规制定者意识到风险管理的必要，并成为标准更新的主要推动者。1. 4Risk Management application / RM应用应用 There is a general requirement to perform the risk management process as specified in ISO 14971. (See Clause 4.2.2 in amendment 1 of IEC 60601

4、-1)4.2章总要求，依据ISO14971执行风险管理过程According to IEC 60601-1 2005, there can be no investigation to this standard without the Manufacturers Risk Management File being available.没有风险管理文件，不能按IEC60601标准测试/评估产品5RISK CONTROL / 风险控制风险控制What can be done to control risks in Medical Devices?风险控制措施及优先顺序Elimination -

5、 eliminate the hazard or hazardous situation;消除 （固有安全设计）Engineering controls - installing machine guarding;工程控制（防护措施）Administrative controls - establish requirements for training, create operators instructions;Implement Warnings and Marking;管理控制 （安全信息）6Risk Evaluation / 风险评价风险评价Level水平Human (Impact

6、to Physical Being)对人的影响Biological Impact生物学影响Environmental Damage环境影响环境影响(1) Minor轻微No Injury or light injury requiring only first aid treatment 无或轻微伤害May not cause human disease, if does, the disease is unlikely to spread to the community and there is usually effective prophylaxis or treatment avai

7、lable;不会导致疾病；不太可能传播，能有效预防或治疗Reversible可逆的(2) Moderate中等Any injury/ health hazard leading to hospitalization or to temporary disability住院或暂时丧失机能Can cause severe human disease, not ordinarily spread by casual contact from one individual to another; it may spread to the community, but there is usually

8、effective prophylaxis or treatment available导致较重疾病，一般不会通过偶热接触传播；可能传播，但通常能有效预防或治疗Reversible but takes years可逆但需要较长时间(3) Major灾难性的Fatality, permanentdisability or life threatening disease 永久丧失机能或威胁生命疾病Can cause lethal human disease, may be readily transmitted from one individual to another, or from an

9、imal to human or vice-versa directly or indirectly, or casual contact, it may spread to the community; usually no effective prophylaxis or treatment available致命疾病，可能容易直接或间接传播，通常不能有效预防或治疗Irreversible不可逆Severity Categories and Description / 严重度类型及描述严重度类型及描述7Risk Evaluation / 风险评价风险评价Level水平Events Freq

10、uency 事件发生概率(1) Remote非常少Undesired event which may occur but is unlikely也许发生但不太可能(2) Occasional偶然Undesired event which is probable but does not occur very often可能发生但不经常(3) Frequent经常Undesired event which is very probable and can occur in most circumstances非常可能发生，多数情况下都会发生Risk probability and descrip

11、tion / 概率及描述概率及描述8Risk Evaluation / 风险评价风险评价Risk matrix to determine Risk Level/风险矩阵风险矩阵 Likelihood 可能性Severity 严重度Remote非常少Occasional偶然Frequent经常Minor 轻微轻微Low RiskLow RiskMedium RiskModerate 中等中等Low RiskMedium RiskHigh RiskMajor 灾难性的灾难性的Medium RiskHigh RiskHigh Risk Likelihood 可能性Severity 严重度Remote

12、 (1)非常少Occasional (2)偶然Frequent (3)经常Minor 轻微轻微 (1)123Moderate 中等中等 (2)246Major 灾难性的灾难性的 (3)3699Risk Evaluation / 风险评价风险评价Risk Score评分Risk Level风险水平Acceptability of Risk风险可接受性Required Actions要求的控制措施4 High Risk高风险Not Acceptable不可接受Unacceptable until the risk level is brought to acceptable level.Risk

13、controls should not be overly dependant on personal protective equipment. Controls measures should focus on elimination, substitution and engineering controls.必须降低到可接受的水平。风险控制不能过度依靠人员。应采取消除，替代和工程控制措施。Risk control will not change the severity but only the probability.Acceptability of Risk / 风险可接受性1.

14、10Responsibility of the Manufacturer / 生产商的职责生产商的职责“The manufacturer shall .” 生产商必须 Establish and maintain a process for Risk Management complying with ISO 14971建立并维护符合ISO14971的风险管理过程Assess the effectiveness of the Risk Management Process when assessing, mitigating (to an acceptable level) and monit

15、oring of identified risks评估风险管理过程的有效性Specify its policy including the level of acceptable risk for the manufactured medical products制定风险管理方针和可接受风险水平Ensure that the risks from all identified hazards have been considered确保所有识别的危害导致的风险都进行了管理Record this activities in the Risk Management File风险管理活动应形成记录P

16、rovide evidence提供证据2. 11The role of CBTL 实验室的职责实验室的职责 Related to RM 风险管理相关：CBTL must verify that the risk management process is in place 实验室必须验证_制造商实施了风险管理过程CBTL must verify the existence of Manufacturers policy for determining acceptable risk taking intoaccount: 实验室必须验证制造商制定的风险可接受准则的方针考虑了：Relevant

17、International Standards, and national or regional regulations 相关的国际标准，国家或地区的法规Available information (state-of-the-art) 可用的信息 （最新技术水平）Known stakeholder concern 利益相关方的关注点12The role of CBTL 实验室的职责实验室的职责For the Device Under Test 测试设备相关CBTL must inspect provided documentation 实验室必须检查制造商提供的文件CBTL must ver

18、ify that the Manufacturers responsibilities have been assumed and fulfilled 实验室必须验证制造商已经履行了职责CBTL must verify that the Risk Management Plan has been appropriately implemented 实验室必须验证制造商适当的执行了风险管理计划CBTL must verify that the Risk Acceptability Criteria have been applied to Risk Acceptability decisions

19、 实验室必须验证风险可接受准则得到应用CBTL must verify compliance with IEC60601-1 实验室必须验证符合IEC60601-113CBTL and manufactures policyCBTL must review and understand manufactures policy and verify that declared risk acceptability is in accordance with manufacturers policy 实验室必须评审并理解制造商的方针，确定的可接受风险符合方针However, it is not C

20、BTLs role to criticize manufacturers criteria for acceptance 制定可接受风险的准则是制造商的职责 CBTL is assessing the understanding of the standard and is expected to “stick” to the standard 实验室评估对标准的理解 It is not enough that the Risk Management File exists. CBTL must collect the evidence. No blind acceptance. 有风险管理文

21、件不是全部2. 14Tools developed by RM Task Force风险管理工作组提供的工具风险管理工作组提供的工具- OD-2044, Guidance for the evaluation of risk management in Medical Electrical Equipment 医疗器械风险管理评估指南 OD-2044- Risk Management Results Tables for use with the IEC 60601-1 TRF风险管理检查表 （IEC60601-1 测试报告模板）3. 15Tools developed by RM Task

22、Force风险管理工作组提供的工具风险管理工作组提供的工具OD-2044 Provides mapping with all the clauses of IEC 60601-1:2005 which require risk management, and the applicable clauses in ISO 14971 and guidance considerations for application of RM criteria 提供IEC60601-1条款和ISO14971条款的对应关系。 风险管理标准应用指南 Includes clauses from IEC 60601-

23、1 which refer to inspection of the manufacturers risk management file, risk control measures and risk management process 检查要求 RM Tables containing reference to the manufacturers documents intended to support objective evidence of compliance 附件 no. 1： 符合性证据的文件16Tools developed by RM Task Force风险管理工作组

24、提供的工具风险管理工作组提供的工具IEC 60601-1 TRF / IEC60601-1 测试报告模板To assess the requirements for Risk Management process required by IEC 60601-1, the CB Scheme utilizes Risk Management Results Tables为评估601要求的风险管理过程，CB 组织适用风险管理结果表 RM Tables are used in conjunction with the test data tables风险管理结果表盒测试数据表一起使用RM Table

25、s containing reference to the manufacturers documents intended to support objective evidence of compliance风险管理结果表包括对符合性证据的参考3. 17IECEE suggested WORKFLOW 建议的工作流程建议的工作流程IECEE Guidance documentfor the evaluation to IEC 60601-1 3rd ed. 1) - Establish Relevant clauses of IEC60601-1 to be supported with

26、RM documentation (further, refer to table 1 of OD-2044 to identify which clauses from 14971 need to be documented) 确定需要风险管理文件支撑的标准条款4. 18IECEE suggested WORKFLOW建议的工作流程建议的工作流程IECEE Guidance documentfor the evaluation to IEC 60601-1 3rd ed. 2) - Verify required documentation and identify reference po

27、ints to be listed in the TRF. 验证文件并记录证据到TRF - In case RM influences the tests. Identify the test, identify the parameters, identify pass/fail criteria 如果风险管理影响测试，确定测试，测试参数，判据 To Verify the required documentation (for lab):验证文件 - Always remember the test is to verify compliance with IEC60601-1 只验证IEC

28、60601-1的要求 - For the Device Under Test 只针对被测设备 - The process is in place 风险管理过程实施 - The Risk Management Plan has been appropriately implemented 风险管理计划适当的执行19IECEE suggested WORKFLOW建议的工作流程建议的工作流程3)- Perform verification and report the results in the TRF tables 测试验证，报告结果测试验证，报告结果4. 2020IEC 60601-1 4.

29、2RISK MANAGEMENT PROCESS for MEEQUIPMENT or ME SYSTEMS医用电气设备或医用电气系统的风险管理过程医用电气设备或医用电气系统的风险管理过程- standard says: A RISK MANAGEMENT PROCESS complying with ISO 14971 shall be performed. 符合符合ISO14971的风险管理过程必须执行。的风险管理过程必须执行。- manufacture and test lab to follow: 4.2 RM Results Table (in TRF, Ver. g) 制造商和试验

30、室依据：风险管理结果表制造商和试验室依据：风险管理结果表4.2- Evidence required by the standard: manufacture to provide and test lab to evaluate, (AS IMPORTANT AS TEST RESULT TABLES) 标准要求的证据：制造商应提供，试验室应评估标准要求的证据：制造商应提供，试验室应评估 （与测试结果一样重要）（与测试结果一样重要）5. Example 2121IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.

31、22222IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2- ISO 14971 3.3 Management Responsibility (3.3a) ISO 14971 3.3管理管理职责职责(3.3a)- Policy for determining acceptable risk 确定可接收确定可接收风险风险准准则则的方的方针针 - Take into account 应应考考虑虑 - Relevant International Standards, and national or regiona

32、l regulations 相关国相关国际标际标准，和国家或地区法准，和国家或地区法规规 - Available information (state-of-the-art) 可用信息（可用信息（ 最新技最新技术发术发展水平展水平 ） ） - Known stakeholder concern 了解了解利益相关者的关注利益相关者的关注2323IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2- ISO 14971 3.3 Management Responsibility (3.3a) - evidence f

33、rom Risk Management Procedure - ISO 14971 3.3管理管理职责职责(3.3a) -来自来自风险风险管理程序的管理程序的证证据据2424IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2- ISO 14971 3.3 Management Responsibility (3.3a) - filling TRF RM Results Table clause 4.2 ISO 14971 3.3管理管理职责职责(3.3a) -填写填写 风险管理结果表风险管理结果表 - 条款条款

34、4.22525IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 3.5 Risk Management Plan (3.5e)ISO 14971 3.5 风险风险管理管理计计划划(3.5e)- The manufacturer shall prepare a risk management plan in accordance with the risk management process.制造商应根据风险管理过程准备风险管理计划- This plan shall includee) cr

35、iteria for risk acceptability-此计划应包括e)风险可接受的准则2626IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 3.5 Risk Management Plan (3.5e)- evidence from Risk Management PlanISO 14971 3.5 风险管理计划(3.5e)-来自风险管理计划的证据2727IEC60601-1 TRF 4.2 RM RESULTS TABLE IEC60601-1 TRF 风险管理结果表风险管理结果

36、表4.2ISO 14971 3.5 Risk Management Plan (3.5e)- evidence from Risk Management Plan （ （link to RM procedure chapter 5.4) ISO 14971 3.5 风险管理计划(3.5e)-来自风险管理计划的证据 （链接至风险管理程序章节5.4）2828IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 4.2风险管理结果表风险管理结果表 ISO 14971 3.5 Risk Management Plan (3.5e)- evidence fr

37、om Risk Management Plan (link to RM procedure chapter 5.6) ISO 14971 3.5 风险管理计划(3.5e) -来自风险管理计划的证据 （链接至风险管理程序章节5.4）2929IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 4.2风险管理结果表风险管理结果表ISO 14971 3.5 Risk Management Plan (3.5e)- filling TRF RM Results Table clause 4.2ISO 14971 3.5 风险管理计划(3.5e)- 填写风险

38、管理结果表条款4.23030IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 4.2风险管理结果表风险管理结果表ISO 14971 4.3 Hazard IdentificationISO 14971 4.3危害危害识别识别Standard says:- The manufacturer shall compile a list of known or foreseeable hazards associated with the medical device in both normal and fault conditions.标准要求：-

39、制造商应编制一个在正常与故障条件下，伴随医疗器械发生的已知或可预见危害列表。3131IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 4.3 Hazard Identification ISO 14971 4.3危害危害识别识别- Evidence from “Risk Management Procedure” 来自来自“ “风险风险管理程序管理程序” ”的的证证据据3232IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风

40、险管理结果表4.2ISO 14971 4.3 Hazard IdentificationISO 14971 4.3危害危害识别识别- Evidence from “Hazard Identification document” 来自来自“ “风险风险管理程序管理程序” ”的的证证据据3333IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 4.3 Hazard IdentificationISO 14971 4.3危害危害识别识别- Evidence from “Hazard Identif

41、ication document” (may refer to annex D of 14971) 来自来自“ “危害危害识别识别文献文献” ”的的证证据（可参考据（可参考14971附附录录D） ）3434IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 4.3 Hazard IdentificationISO 14971 4.3危害危害识别识别- filling TRF RM Results Table clause 4.2 填写风险管理结果表填写风险管理结果表条款条款4.23535IEC

42、60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2Standard says:- Any residual risk that remains after the risk control measure(s) are applied shall be evaluated using the criteria defined in the risk management plan 风险控制措施实施之后所剩余的残留风险，应运用定义在风险管理计划中的准 则进行评估。- Acceptance criteria 接收准则-

43、ALARP (as low as reasonably practicable) 合理可行ISO 14971 6.4 Residual Risk EvaluationISO 14971 6.4 残留残留风险评风险评估估3636IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 6.4 Residual Risk EvaluationISO 14971 6.4 残留残留风险评风险评估估 - Evidence from “Risk Management Procedure” 来自来自“ “风险风险

44、管理程序管理程序” ”的的证证据据3737IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 6.4 Residual Risk EvaluationISO 14971 6.4 残留残留风险评风险评估估- Evidence from “Risk Management Summary” 来自来自“ “风险风险管理管理总结总结” ”的的证证据据3838IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 149

45、71 6.4 Residual Risk EvaluationISO 14971 6.4 残留残留风险评风险评估估- Evidence from “Risk Management Summary”-来自来自“ “风险风险管理管理总结总结” ”的的证证据据3939IEC60601-1 TRF 4.2 RM RESULTS TABLEIEC60601-1 TRF 风险管理结果表风险管理结果表4.2ISO 14971 6.4 Residual Risk EvaluationISO 14971 6.4 残留残留风险评风险评估估 - filling TRF RM Results Table clause 6.4 填写风险管理结果表填写风险管理结果表条款条款4.240If possible,cl. 7.9.3.2 as example41Thank You for listeningAny comments or questions would be welcome!