iso13485：2016医疗器械风险管理报告

Page 1 of 46 Limited 有限公司Risk Analysis report 风险分析报告Product（产品）: Type/Model（型号）: Effective date（有效期）: 5/24/2018-5/23/2019 Document No.（文件编号）: Version（版本）: A0 Department(部门): Technical Department (工程部) Made编制Check审核Approval批准Page 2 of 46 Contents内容1 Foreword 前言3 2 Scope范围3 3 Application information适用信息3 3.1 Policy, directive and standard政策，指令和标准3 3.2 The information of product 产品信息4 3.3 Other source of information 其他资源信息4 3.4 Team of risk management风险管控小组4 3.5 Instruction of product产品指导5 4 Risk analysis 风险分析5 4.1 Risk analysis procedure 风险分析过程5 4.2 Intended use/intended purpose and identification of characteristics related to the safety 适用范围/预期目的以及安全相关的特征分辨5 4.3 Identification of known or foreseeable hazards and Estimation of the risk(s) for each hazard 已知或可预见的风险辨别以及对每种危险的预估9 4.4 Risk Estimation 风险预估10 5 Risk evaluation 风险评估12 6 Risk control 风险管控12 6.1 Risk reduction and implementation of control measure(s)降低风险及风险管控的措施12 6.2 Risks arising from risk control measures风险管控措施带来的风险16 6.3 Completeness of risk evaluation风险评估的完成16 7 Overall residual risk evaluation总体剩余风险评估16 8 Information of in production and use 生产及使用时信息16 9 Conclusion总结18 Page 3 of 46 RISK ANALYSIS REPORT 1. Foreword 前言This article is the report of the risk analysis of this product. This report shows all the potential risks and the reason cause these risks happen, also estimate the rate and the level of all kinds of risks maybe cause the serious result, if a item can not be acceptable, which need to adopt a measure to reduce the risk level and estimate the rate and level after. Finally, make all the items acceptable. 本文是该产品的风险分析的报告。该报告显示了所有潜在的风险及造成这些风险的原因，同时预估了可能会导致严重后果的各种风险的水平和等级，如果有一个项目不能被接受，就需要采取措施，以降低风险等级并预估之后的风险水平和等级。最后，使所有项目变成可以接受。2. Scope 范围This reportis applicable to the product of Electrical Lice Comb which including the following parts: 1. PCB 2. Metal comb 3. Alkaline battery 4. Plastic enclosure 这份报告适用于电动除虱梳，它包括以下几个部分内容：1.电子线路板2.五金梳3.干电池4.塑胶外壳3. Application information: 应用信息3.1 Policy, directive and standard 政策，指令和标准1) 93/42/EEC (MDD) Medical Devices Directive 2) Regulation (EU) 2017/745 (MDR) Medical Device Regulation3) ISO 13485:2016 Medical device-Quality management system-requirements for regulatory 4) EN ISO 14971:2016 Medical devices - Application of risk management to medical devices 5) IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General

Page 4 of 46 requirements for basic safety and essential performance 6) IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests 7) IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 1）93/42 / EEC指令（MDD）医疗器械指令2) Regulation (EU) 2017/745 (MDR) 醫療器材法規2）ISO 13485：2016医疗设备质量管理监管系统的要求3）EN ISO 14971：2016医疗器械- 医疗器械的风险管理应用4）IEC 60601-1：2005 + A1：2012 / EN 60601-1：2006医用电气设备- 第1部分：基本安全和基本性能通用要求5）IEC 60601-1-2：2014 / EN 60601-1-2：2014医用电气设备- 第1-2部分：安全通用要求- 并列标准：电磁兼容性- 要求和试验6）IEC 60601-1-11：2015医用电气设备- 1-11部分：基本安全和基本性能通用要求- 并列标准：在家庭医疗保健环境中使用医用电气设备和医用电气系统的要求3.2 The information of product产品的信息Design program, Schematic, Standard of product, PCB layout, Instruction of product. 设计方案，原理，产品标准，PCB布局，产品说明书。3.3 Other source of information其他信息来源Customer suggestion, Record of accident, Professional documentary, Internet 客户建议，事故记录，专业文件，网络信息3.4 Team of risk management: 风险管理小组Name 姓名Title 职位The duty in the risk management风险管理中的责任David Wong 黄竞强General Manager 总经理Provide the resources needed; approve the plans and the reports of risk management 提供需要的资源，批准风险管理报告和方案

Page 5 of 46 Bob Wan 尹兆生Management Representative 管理者代表Supervise, organize and implement the risk management activities; participate in the risk analysis and evaluation. 监管，组织和实施风险管理活动，参与风险分析和评估Ben Chan 陈锦锋Head of Technical Department 工程部经理Responsible for product technical and quality risk management; participate in the risk analysis and evaluation. Organize to make the risk management plan and report. 负责产品技术和品质的风险管控；参与风险分析和评估。组织实施风险管理计划和报告。He Xiaoyang 何晓阳Head of Product Department 生产部经理Provide information related to risk during production process; implement risk control measures in the process of production, reduce or eliminate the risk; participate in the risk analysis and evaluation. 提供生产过程中与风险有关的信息；在生产过程中执行风险管控措施，减少或者降低风险；参与风险分析和评估Bob Wan 尹兆生Head of Quality Department 品质部经理Validate the results of risk control measures; participate in the risk analysis and evaluation. 认证风险管控措施的结果，参与风险分析和评估Patrick Lai 黎志聪Head of Marketing Department 市场部经理Responsible for tracking the quality of products sold, and collect the related information; participate in the risk analysis and evaluation. 负责追踪已售产品的品质跟踪，收集相关信息；参与风险分析和评估3.5 Instruction of product产品说明Refer to Operating Manuals. 参见说明书4. Risk analysis 风险分析4.1 Risk analysis procedure 风险分析过程Refer to Risk Management Plan (Document No.: RM-9022-01 Version: A0) 参见风险管理计划（文件号：RM-9022-01 版本：A0）4.2 Intended use/intended purpose and identification of characteristics related to the safety (Annex C of EN ISO 14971:2016) 预期用途/预期目的和相关的安全特征的标识（EN ISO 14971:2016附件C）NO编号Items内容The specialty of character 特征C.2.1 What is the intended use and how is the medical device to be used? 用途以及如何使用此医疗器械？To be used for removing lice from head hair. 用于去除头发上的虱子