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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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保健品灭菌.干热法.医疗器械灭菌过程的开发,验证和常规控制要求
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
参考页数：74P;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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医疗器械的生物学评价. 样品制备和参考材料
Biological evaluation of medical devices. Sample preparation and reference materials
参考页数：34P;A4
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医疗用气体混合器.独立气体混合器
Gas mixers for medical use. Stand-alone gas mixers
参考页数：18P.;A4
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集合医疗设备的IT网络的风险管理应用程序.作用,职责和行为
Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities
参考页数：46P.;A4
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医疗器械的生物学评价.第11部分:全身毒性试验(ISO 10993-11-2006)
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)
参考页数：38P.;A4
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医疗器械的生物学评价.第17部分:浸出物允许限量的确定(ISO 10993-17-2002)
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
参考页数：36P.;A4
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医疗器械的生物学评价.第18部分:材料的化学表征(ISO 10993-18-2005)
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
参考页数：28P.;A4
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