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医疗电气设备. 第1-10部分: 基本安全和主要性能的通用要求. 辅助标准: 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：10P.;A4
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医疗电气设备. 第1-6部分: 基本安全和主要性能的特殊要求. 辅助标准: 可用性
Medical electrical equipment - Part 1-6 : general requirements for basic safety and essential performance - Collateral standard : usability
参考页数：12P.;A4
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医疗电气设备. 第1-12部分: 基本安全和主要性能的通用要求. 辅助标准: 对旨在使用应急医疗服务环境的医疗设备和医疗电气系统的要求
Medical electrical equipment - Part 1-12 : general requirements for basic safety and essential performance - Collateral standard : requirements for medical equipment and medical electrical systems intended for use the emergency medical services environmen
参考页数：60P.;A4
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医疗电气设备. 第2-30部分: 自动无创血压计基本安全和基本性能的特殊要求
Medical electrical equipment - Part 2-30 : particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
参考页数：17P.;A4
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医疗电气设备. 第2-68部分: 与电子加速器, 轻离子束治疗设备以及放射性核束治疗设备一起使用的基于X射线的图像引导放射治疗设备的基本安全和基本性能的特殊要求
Medical electrical equipment - Part 2-68 : particular requirements for basic safety and essential performance of X-ray based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam the
参考页数：74P.;A4
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医疗电气设备. 辐射剂量文档. 第1部分: 放射线照相术和放射线透视的辐射剂量结构化报告
Medical electric equipment - Radiation dose documentation - Part 1 : radiation dose structured reports for radiography and radioscopy
参考页数：39P.;A4
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医疗设备的生物学评价.第3部分:遗传毒性、致癌性和生殖毒性试验
Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity
参考页数：49P.;A4
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健康软件.第1部分:产品安全通用要求
Health Software - Part 1 : general requirements for product safety
参考页数：35P.;A4
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医疗器械的生物学评价.第15部分:金属与合金降解产物的识别与定量
Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys.
参考页数：23P;A4
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医疗设备的生物学评估.第17部分:可浸出物质容许限值的确定
Biological evaluation of medical devices - Part 17 : Establishment of allowable limits for leachable substances.
参考页数：37P;A4
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