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医疗电气设备.第1-10部分:基本安全和重要性能的一般要求.附属标准:生理闭环控制器的开发要求
Medical electrical equipment - Part 1-10 : general requirements for basic safety and essential performance - Collateral Standard : requirements for the development of physiologic closed-loop controllers.
参考页数:45P.;A4
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医疗电气设备.第1-9部分:基本安全和重要性能的通用要求.附属标准:环境意识设计的要求
Medical electrical equipment - Part 1-9 : general requirements for basic safety and essential performance - Collateral Standard : requirements for environmentally conscious design.
参考页数:35P;A4
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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:33P;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.间接标准:电磁兼容性.要求和试验
Medical electrical equipment - Part 1-2 : general requirements for basic safety and essential performance - Collateral standard : electromagnetic compatibility - Requirements and tests.
参考页数:130P.;A4
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医疗电气设备.第2-33部分:医疗诊断用磁共振设备基本安全和基本性能的特殊要求.
Medical electrical equipment - Part 2-33 : particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
参考页数:127P;A4
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医用电气设备.第1-8部分:基本安全和基本性能的通用要求.间接标准:医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南
Medical electrical equipment - Part 1-8 : general requirements for basic safety and essential performance - Collateral Standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
参考页数:82P.;A4
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体外诊断用医疗器材.微生物培养介质.培养介质的性能标准
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media.
参考页数:5P.;A4
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实验室医学.参考测量实验室的要求
Laboratory medicine - Requirements for reference measurement laboratories.
参考页数:22P.;A4
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与体外诊断试剂感染相关的风险消除或降低
Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
参考页数:10P.;A4
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体外诊断医疗装置.收集来自于人体的试样(血液除外)用一次性容器
In vitro diagnostic medical devices - Single-use receptables for the collection of specimens, other than blood, from humans.
参考页数:21P.;A4
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