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体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
参考页数：16P.;A4
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医疗电气设备. 对呼吸机依赖患者的家庭医疗保健环境通风机基本安全和基本性能的特殊要求
Medical electrical equipment. Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
参考页数：104P.;A4
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医疗电气设备.人体体温测量用体温计的基本安全性和主要性能的详细要求
Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
参考页数：66P.;A4
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临床实验室药物.体外诊断医疗设备.由制造商确认的用户质量控制程序
Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
参考页数：18P;A4
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临床实验室测试和体外诊断试验系统.传染者的敏感性测试和抗菌剂敏感性试验装置的性能评定.抗菌剂敏感性试验装置的性能评定
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test devices
参考页数：18P;A4
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非侵入式血压计.自动非侵入式血压计的整个系统准确度测定的试验规程
Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
参考页数：36P.;A4
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医疗电气设备.第2-35部分:利用毯、衬垫和床垫的加温设备和医用加温设备的基本安全性和必要性能要求(IEC 80601-2-35-2009+Cor.-2012+Cor.-2015+A1-2016);德文版本EN 80601-2-35-2009+A11-2011+AC-2015+A1-2016
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009 + Cor.:2012 + Cor.:2015 + A1:2016); German version EN 80601-2-35:2009 + A11:2011 + AC:2015 + A1:2016
参考页数：83P.;A4
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医疗电气设备.第2-30部分:自动非入侵式血压测量计的基本安全和主要性能的特定要求(IEC 80601-2-30-2009+Corrigendum Jan. 2010+A1-2013);德文版本EN 80601-2-30-2010+A1-2015
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2009 + Corrigendum Jan. 2010 + A1:2013); German version EN 80601-2-30:2010 + A1:2015
参考页数：69P.;A4
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体外诊断医疗器械.体外诊断试剂的稳定性评定(ISO 23640-2011).德文版本EN ISO 23640-2015
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
参考页数：15P.;A4
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非侵入式血压计. 第2部分: 自动测量类型的临床研究 (ISO 81060-2-2013); 德文版本EN ISO 81060-2-2014
Non-invasive sphygmomanometers - Part 2: Clinical invastigation of automated measurement type (ISO 81060-2:2013); German version EN ISO 81060-2:2014
参考页数：52P.;A4
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