BRITISH STANDARDBS EN 13612:2002Corrigendum No. 1Incorporating Performance evaluation of in vitro diagnostic medical devicesThe European Standard EN 13612:2002 has the status of a British StandardICS 11.10012 &23<,1* :,7+287 %6, 3(50,66,21 (;&(37 $6 3(50,77(' %< &23<5,*+7 /$:...
BSEN13612:2002 体外诊断医疗装置的性能评估 欧洲标准EN13612:2002具有英国标准的同等效力! 翻译:陈晓亮 (本翻译虽力求准确,但译者专业知识和英文水平有限,不可避免地会出现错误。本翻译只做参考,译者不承担法律责任。) 国家前言 该英国标准是EN13612:2002的官方英文标准,2002年12月修 ...
DIN EN 13612:2002-08的发布历史信息,体外诊断医疗器械性能评价, Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts,
1 Performance evaluation of in vitro diagnostic medical devices The European Standard EN 13612:2002 has the status of a British Standard ICS 11.100 ? BS EN 13612:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee,...
内容提示: EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13612March 2002ICS 11.100 Incorporates corrigendum December 2002English versionPerformance evaluation of in vitro diagnostic medical devicesDétermination des performances des dispositifs médicauxpour diagnostic in vitroLeistungsbewertung von In-vitro...
BS EN 13612:2002(2003) 被代替标准 99/563275 DC-1999 适用范围 本欧洲标准适用于体外诊断医疗器械(IVD MD)的性能评估,包括用于自检的 IVD MD。它规定了制造商对性能评估研究的规划、实施、评估和记录的责任和一般要求。它不适用于某些 IVD MD 或特定用途的特定评估计划。注:有关特定评估计划的精选出版物,...
内容提示: DEUTSCHE NORM August 2002Leistungsbewertung von In-vitro-DiagnostikaDeutsche Fassung EN 13612:2002Text in Deutsch und EnglischEN 13612ICS 11.100Performance evaluation of in vitro diagnostic medical devices;German version EN 13612:2002, German and English textsDétermination des performances des ...
EN13612：2002中文翻译 98/79/EC指令，关于体外诊断医疗设备（IVD MDs）requires in Annex III, section 3,indent 11 and section 6.1, in Annex IV, section 3.2 c) and in Annex V, section 3，生产商在他的技术文档里提供证据，表明该IVD MD象所声明的一样表现，是否这些声明是由技术，分析或诊断支持...
体外诊断试剂IVD欧盟EN13612性能评估部分中英 3 General requirements for the performance evaluation 3.1 Responsibilities and resources The manufacturer takes the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of ...
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