医疗电机设备一般安全规格要求工作坊.pdfVIP

醫療及保健行業培訓 Bio-Medical Healthcare Industry Support Training: IEC 60601-1 醫療電機設備一般安全規格要求工作坊醫療電機設備一般安全規格要求工作坊 醫療電機設備一般安全規格要求工作坊醫療電機設備一般安全規格要求工作坊 Workshop on IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment 15/01/2010 (Fri, 星期五) 18/01/2010 (Mon, 星期一) Background 背景背景: 背景背景 In the medical and healthcare sector, medical equipment must go through proper safety testing to ensure their safety to both operators and patients before legally marketed. In order to pass the safety requirements, the medical electrical equipment manufacturers must conform and adhere to stringent international safety standard, IEC 60601-1 to design medical electrical devices. IEC 60601-1 (Edition 3) is published by the International Electrotechnical Committee (IEC). This standard comprises the complete set of regulations for the design of safe medical electrical devices, which allows manufacturers to practice safe design of medical device in design phase. HKPC is organizing the present workshop to introduce IEC 60601-1 and the best practice of the standard. It will answer the following questions: • What is IEC 60601 and why do medical devices need to meet this safety standard? • How to classify and recognize medical electrical devices according to IEC 60601-1? • What are the safety electrical and mechanical construction requirements in IEC 60601-1? • How is a medical electrical device to be designed against possible hazards? Objectives 目的目的: 目的目的