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医疗器械生物学评价.第5部分:细胞毒性体外试验法(ISO 10993-5-2009)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
参考页数：46P.;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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医疗电气设备.基本安全性和必要性能的一般要求.附属标准.家庭保健环境中使用的医疗电气设备和医疗电气系统要求
Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
参考页数：62P;A4
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健康信息学.个人健康设备通信.装置专门化.药物监控器
Health Informatics. Personal health device communication Device specialization. Medication monitor
参考页数：80P;A4
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医疗器械.医疗器械风险管理的应用
Medical devices. Application of risk management to medical devices
参考页数：106P;A4
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医疗电气设备.腹膜透析设备基本安全性和必要性能的详细要求
Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
参考页数：24P;A4
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医疗电气设备.基本安全性和必要性能的一般要求
Medical electrical equipment. General requirements for basic safety and essential performance
参考页数：386P;A4
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医疗器械的生物学评价.聚合物医疗器械降解产物的鉴定与定量
Biological evaluation ofmedical devices.Part 13: Identification and quantificationof degradation products from polymericmedical devices
参考页数：28P.;A4
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医疗设备用动物组织及其衍生物.风险管理的应用
Medical devices utilizing animal tissues and their derivatives. Application of risk management
参考页数：40P.;A4
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医用电气设备.体外诱导碎石设备安全性规范
Medical electrical equipment. Particular requirements for safety. Specification for equipment for extra-corporeally induced lithotripsy
参考页数：24P.;A4
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