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医疗设备用动物组织及其衍生物.第3部分:病毒和传染性海绵状脑病(TSE)试剂的销毁和/或失效的确认
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
参考页数:30P.;A4
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医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
参考页数:22P.;A4
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医疗设备用动物组织及其衍生物.第1部分:风险管理的应用
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
参考页数:34P.;A4
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医疗器械的生物学评价. 风险管理过程中生物学评价行为指南
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
参考页数:15P.;A4
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医疗电气设备.筛选温度计用鉴定发热人群用部署、实施和操作指南
Medical electrical equipment - Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
参考页数:23P.;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:3P.;A4
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临床实验室测试和体外诊断试验系统.检测体外抗菌剂抗传染病中酵母菌的活性的标准方法
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
参考页数:18P;A4
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医用输液器械.第4部分:一次性使用,重力给水的输液器.修改件1
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Amendment 1
参考页数:8P;A4
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医疗设备的生物评估.第4部分:血统相互作用试验筛选
Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood
参考页数:86P.;A4
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医疗器械的生物学评定.降解产物和可滤取物的毒物动力学研究设计
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables
参考页数:26P.;A4
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