ISO14971风险管理标准.pptVIP

WCC * 9 Production and post-production information The manufacturer shall establish, document and maintain a system to collect and review information in the production and the post-production phases to evaluate 制造商应建立和保持一个收集包括同类产品的生产和上市后信息的系统，并形成文件，用于确定: a) if previously unrecognized hazards are present;是否有未识别的风险？ b) if the estimated risk(s) arising from a hazard is no longer acceptable; 以前评价的风险是否不再可以接受？ c) if the original assessment is otherwise invalidated. 是否最初的评定不再有效 The manufacturer should consider the mechanisms by which information collected and processed; 制造商应考虑信息收集和加工的方法 The manufacturer should also consider new or revised standards. 标准的更新也需要考虑 风险再评价，why？ 风险识别不完全 临床暴露，如多支架使用； 风险估计不准确 S/P/D, 高估，成本增加，低估， 风险失控； 设计更改，更改对器械整体性能的影响 法规的变更，如对关节、支架和起搏器等植入器械的追溯性法规。 End of part A * WCC * How to find the hazards?如何识别危害 Sources to find hazard识别危害的资料包括: 1. Standards 相关标准，如ISO 10555－1对导管的断裂力有详细规定 2. Existing risk analyses of similar products 类似产品的风险分析 3. Interviews with the design engineers 从设计工程师处获得信息 4. Interviews with users of similar products从器械的使用者处获得信息 5. Experience of the sales people 销售人员的经验 6. Brainstorming in Risk Assessment team 风险管理团队的头脑风暴活动 7. Analysis of government Incident Reports 分析政府的事故报告 8. Examination of existing risk mitigation measures; 检验风险控制措施 9. Information from the field for similar products, e.g. complaints, incidents 相似产品的信息，如顾客抱怨，事故等…………… WCC * Identification of hazards危害识别 Annex E：Examples of hazards 附录E中的危害举例 Energy 能量危害 biological and Chemical生物和化学危害 operational 操作危害 information 信息危害 Electromagnetic energy (Leakage current) 漏电 Radiation energy Thermal energy (High temperature Low temperature) Mechanical energy (Moving parts) Biological (Bacteria cross-infection) 细菌交叉感染 Chemical (Residues solution) Biocompatibility (Toxicity of chemical agent) Function (inappropriate Output) 不正确的输出 Use error (reuse of disposable MD) Labelling (Incomplete instruction