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医疗设备.医疗设备.不良事件的层级编码结构.第1部分:事件类型编码
Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
参考页数：22P.;A4
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医疗器械.用于医疗器械标签、作标记和提供信息的符号.第2部分:符号的制定、筛选和批准
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
参考页数：24P.;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. 第2-7部分: 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 - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
参考页数：110P.;A4
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Guidance for assessment and evaluation of changes to drug delivery systems
参考页数：36P.;A4
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医疗器械软件. 第2部分: 医疗器械质量体系软件验证
Medical device software - Part 2: Validation of software for medical device quality systems
参考页数：84P.;A4
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医疗器械. 医疗器械安全性和性能的公认基本原则. 第1部分: 所有非IVD医疗器械的通用基本原则和额外具体基本原则和标准选择指南
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
参考页数：47P.;A4
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医疗器械. 提供医疗器械标签, 标记和信息使用的符号. 第1部分: 通用要求
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
参考页数：25P.;A4
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医用制品的包装原材料.根据良好加工规范(GMP)应用ISO 9001-2015的特殊要求
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
参考页数：79P.;A4
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医疗设备.质量管理.医疗设备命名法数据结构
Medical devices - Quality management - Medical device nomenclature data structure
参考页数：13P.;A4
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医用配供装置
Medical supply units
参考页数：26P.;A4
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