【精品】IEC60601-1 2005 第3版 风险管理简介.ppt

1,iec 60601-1:2005 第3版 风险管理_简介 beijing dec. 2011 路学军 mobile:135 8159 7318 email: xuejun.lu,tv rheinland (china) ltd.,2,iec 60601-1第3版对风险管理的要求,contents/内容 1. risk management of 3rd ed./ 2. responsibility 职责 3. rm tools 风险管理评估指南，风险管理结果检查表 4. suggested workflow to evaluate iec 60601-1 3rd ed. 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,3,iec 60601-1第3版对风险管理的要求,第3版与第2版最主要的区别： 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.,4,risk management application / rm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 60601-1) 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,5,risk control / 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 - 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）,6,risk evaluation / 风险评价,severity categories and description / 严重度类型及描述,7,risk evaluation / 风险评价,risk probability and description / 概率及描述,8,risk evaluation / 风险评价,risk matrix to determine risk level/风险矩阵,9,risk evaluation / 风险评价,risk control will not change the severity but only the probability.,acceptability of risk / 风险可接受性,1.,10,responsibility of the manufacturer / 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 monitoring 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 provide evidence 提供证据,2.,11,the role of cbtl 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 into account: 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 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,12,the role of cbtl 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 verify 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 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iec60601-1,13,cbtl and manufactures policy,cbtl 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 cbtls 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. 有风险管理文件不是全部,2.,14,tools developed by rm task force 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.,15,tools developed by rm task force 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 60601-1 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,16,tools developed by rm task force 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 tables 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.,17,iecee suggested workflow 建议的工作流程,iecee guidance document for the evaluation to iec 60601-1 3rd ed. 1) - establish relevant clauses of iec60601-1 to be supported with 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.,18,iecee suggested workflow建议的工作流程,iecee guidance document for the evaluation to iec 60601-1 3rd ed. 2) - verify required documentation and identify reference points 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iec60601-1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,19,iecee suggested workflow建议的工作流程,- perform verification and report the results in the trf tables 测试验证，报告结果,4.,20,20,iec 60601-1 4.2 risk 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,- standard says: a risk management process complying with iso 14971 shall be performed. 符合iso14971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 （与测试结果一样重要）,5. example,21,21,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,22,22,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,- iso 14971 3.3 management responsibility (3.3a) iso 14971 3.3管理职责(3.3a),- policy for determining acceptable risk 确定可接收风险准则的方针 - take into account 应考虑 - relevant international standards, and national or regional regulations 相关国际标准，和国家或地区法规 - available information (state-of-the-art) 可用信息（ 最新技术发展水平 ） - known stakeholder concern 了解利益相关者的关注,23,23,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,- iso 14971 3.3 management responsibility (3.3a) - evidence from risk management procedure - iso 14971 3.3管理职责(3.3a) -来自风险管理程序的证据,24,24,iec60601-1 trf 4.2 rm results table iec60601-1 trf 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管理职责(3.3a) -填写 风险管理结果表 - 条款4.2,25,25,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,iso 14971 3.5 risk management plan (3.5e) iso 14971 3.5 风险管理计划(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 include e) criteria for risk acceptability -此计划应包括 e)风险可接受的准则,26,26,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,iso 14971 3.5 risk management plan (3.5e) - evidence from risk management plan iso 14971 3.5 风险管理计划(3.5e) -来自风险管理计划的证据,27,27,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,iso 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）,28,28,iec60601-1 trf 4.2 rm results table iec60601-1 trf 4.2风险管理结果表,iso 14971 3.5 risk management plan (3.5e) - evidence from 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）,29,29,iec60601-1 trf 4.2 rm results table iec60601-1 trf 4.2风险管理结果表,iso 14971 3.5 risk management plan (3.5e) - filling trf rm results table clause 4.2 iso 14971 3.5 风险管理计划(3.5e) - 填写风险管理结果表条款4.2,30,30,iec60601-1 trf 4.2 rm results table iec60601-1 trf 4.2风险管理结果表,iso 14971 4.3 hazard identification iso 14971 4.3危害识别,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： -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。,31,31,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,iso 14971 4.3 hazard identification iso 14971 4.3危害识别,- evidence from “risk management procedure” 来自“风险管理程序”的证据,32,32,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,iso 14971 4.3 hazard identification iso 14971 4.3危害识别,- evidence from “hazard identification document” 来自“风险管理程序”的证据,33,33,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,iso 14971 4.3 hazard identification iso 14971 4.3危害识别 - evidence from “hazard identification document” (may refer to annex d of 14971) 来自“危害识别文献”的证据（可参考14971附录d）,34,34,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,iso 14971 4.3 hazard identification iso 14971 4.3危害识别 - filling trf rm results table clause 4.2 填写风险管理结果表条款4.2,35,35,iec60601-1 trf 4.2 rm results table iec60601-1 trf 风险管理结果表4.2,standard says: - any residual risk that remains after the risk control measure(s) are app