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医疗器械的生物学评价.第5部分:体外细胞毒性试验
Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
参考页数：44P;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：23P;A4
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体外诊断用医疗器材.生物本原的样品数量测量.基准测量程序的内容和表示法要求
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures.
参考页数：31P;A4
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体外诊断医疗设备.生物器官样本的定量测量.法定标准物质和辅助文档内容的要求
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation.
参考页数：27P;A4
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医用电气设备.基本安全性和基本性能的一般要求.平行标准:可用性
Medical electrical equipment - Part 1-6 : general requirements for basic safety and essential performance - Collateral standard : usability.
参考页数：31P;A4
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急救安全冲洗器.第4部分:非垂直眼部冲洗器
Emergency safety showers - Part 4 : non plumbed-in eyewash units.
参考页数：11P;A4
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医用电气设备.心电图监测仪.安全、操作和性能的特殊要求
Electromedical equipment. Electrocardiography monitoring equipment. Particular requirements for safety, operating and performances.
参考页数：35P.;A4
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急救安全冲洗器.第3部分:非垂直身体冲洗器
Emergency safety showers - Part 3 : non plumbed-in body showers.
参考页数：11P;A4
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医疗设备的生物学评估.第14部分:陶瓷降解产物的鉴别和定量
Biological evaluation of medical devices - Part 14 : identification and quantification of degradation products from ceramics.
参考页数：21P;A4
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带有医疗设备的信息技术网络的风险管理应用.第1部分:角色,责任和活动.
Application of risk management for IT-networks incorporating medical devices - Part 1 : roles, responsibilities and activities.
参考页数：47P;A4
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