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医疗车辆及其设备.空中救护机.用于空中救护机的医疗装置要求
Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances
参考页数：22P.;A4
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医疗电气设备的通用试验规程
General testing procedures for medical electrical equipment
参考页数：218P.;A4
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医疗电气设备.医疗电气设备的循环试验和维修后试验
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
参考页数：66P.;A4
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包含医疗设备的IT网络风险管理应用应用指南. 医疗保健服务组织 (HDOs) 自我评估自身IEC 80001-1合规性指南
Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
参考页数：112P.;A4
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实施医疗器械用ISO 13485质量管理体系
Implementing an ISO 13485 Quality Management System for Medical Devices
参考页数：196P.;A4
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ISO/TC 84制定标准的过渡时期指南. 医药产品和导管的管理设备
Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
参考页数：14P.;A4
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医疗器械软件. 医疗器械软件生命周期过程的流程参考模式 (IEC 62304)
Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)
参考页数：32P.;A4
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医疗器械厂商提供的信息
Information supplied by the manufacturer of medical devices
参考页数：28P;A4
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医疗器械.不良事件的层级编码结构.事件类型编码
Medical devices. Hierarchical coding structure for adverse events. Event-type codes
参考页数：28P;A4
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医疗电气设备. 基本安全和主要性能的一般要求. 附属标准. 环境意识设计要求
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for environmentally conscious design
参考页数：34P;A4
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