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药品的主要包装材料.以良好加工实践(GMP)为参考ISO 9001-2008应用的特殊要求
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：103P.;A4
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医疗设备的生物学评价.第16部分:对降解产物和可沥滤物的毒理动力学研究方案
Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
参考页数：28P.;A4
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医疗设备软件-软件生命周期过程
Medical device software - Software life-cycle processes
参考页数：54P.;A4
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医用电气设备.第1-2部分:基本安全和基本性能的一般要求.附属标准：电磁干扰.试验和要求
Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
参考页数：82P;A4
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医疗器械.质量管理系统.管理目标的要求
Medical devices -- Quality management systems -- Requirements for regulatory purposes
参考页数：44P;A4
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医疗电气设备. 指南和说明. 电磁抗干扰: 医疗电气设备和医疗电气系统性能
Medical electrical equipment. Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
参考页数：62P.;A4
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医疗器械. 医疗器械可用性工程应用指南
Medical devices. Guidance on the application of usability engineering to medical devices
参考页数：108P.;A4
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医疗器械IT网络的风险管理应用. 应用指南. 确定IEC TR 80001-2-2中已确认安全能力标准指南
Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
参考页数：56P.;A4
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包含医疗设备IT网络的风险管理应用. 应用指南. 分布式报警系统指南
Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance on distributed alarm systems
参考页数：42P.;A4
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包含医疗设备IT网络的风险管理应用. 应用指南. 责任协议指南
Application of risk management for IT-networks incorporating medical device. Application guidance. Guidance for responsibility agreements
参考页数：26P.;A4
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