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The European In-Vitro Diagnostic Medical Devices Directive: Its Implications on the Clinical Marketplace and Healthcare Measurement Standards

机译：欧洲体外诊断医疗器械指令：其对临床市场和医疗保健测量标准的影响

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W.B. de Leer; Ruud M. Lequin;
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年度 2000
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1. The European In-Vitro Diagnostic Medical Devices Directive: Its Implications on the Clinical Marketplace and Healthcare Measurement Standards [J] . Ed W.B. de Leer, Ruud M. Lequin Journal of Laboratory Automation . 2000,第2期

机译：欧洲体外诊断医疗器械指令：其对临床市场和医疗保健测量标准的影响
2. Has the Introduction of the European Parliament Directive 98/79/EC from 1998-10-27- Concerning in-vitro Diagnostic Devices (IVD-Directive) Influenced Performance of Hormone Immunoassay Kits in Terms of Precision and Accuracy? Results from Selected External Quality Assessment (EQA) Schemes between 1993 and 2008 [J] . WILLIAM GRAHAM WOOD Clinical Laboratory . 2009,第3a4期

机译：1998年10月27日引入的欧洲议会指令98/79 / EC-关于体外诊断设备（IVD指令）是否从准确性和准确性方面影响了激素免疫测定试剂盒的性能？ 1993年至2008年间部分外部质量评估（EQA）计划的结果
3. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) [J] . Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann, German Medical Science . 2021,第a期

机译：AWMF AD HOC委员会在体外诊断医疗器械上制造和仅根据监管（欧盟）2017/746（IVDR）在联盟建立的卫生机构内使用的体外诊断医疗器械的咨询意见
4. Modification of the ASTM Platelet and Leukocyte Assay - Use of an Alternative and Clinically Relevant Anticoagulant: An In-vitro Hemocompatibility Assessment of Blood Contacting Medical Devices [C] . Tim Schatz, Abby Beltrame, Sarah Howard, Design of Medical Devices Conference . 2017

机译：ASTM血小板和白细胞测定的修饰 - 使用替代和临床相关的抗凝血剂：血液接触医疗装置的体外血液相位性评估
5. An exploratory case study of the professional teaching and learning practices of surgeons providing instruction in the medical devices and diagnostics industry: Implications for faculty development and endorsement by the professional field. [D] . Kenahan, Rita Anne. 2014

机译：在医疗设备和诊断行业提供指导的外科医生的专业教学实践的探索性案例研究：对专业领域教师发展和认可的启示。
6. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) [O] . Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann, 2021

机译：AWMF临时委员会在体外诊断医疗器械的咨询意见这些医疗器械均仅在工会中建立的卫生机构内根据条例（欧盟）2017/746（IVDR）
7. Proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices. Draft decision of the EEA Joint Committee amending Annex II, technical regulations, standards, testing and certification, to the Agreement on the European Economic Area. COM (95) 130 final, 19 April 1995. [O] . 1995

机译：关于体外诊断医疗器械的欧洲议会和理事会指令的提案。欧洲经济区联合委员会关于修订附件二，技术法规，标准，测试和认证的决定草案，适用于欧洲经济区协定。 COm（95）130决赛，1995年4月19日。
8. Baseline Data on the Availability of Medical Devices and In-Vitro Diagnostic Products [R] . 1980

机译：医疗器械和体外诊断产品可用性的基线数据

The European In-Vitro Diagnostic Medical Devices Directive: Its Implications on the Clinical Marketplace and Healthcare Measurement Standards

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