诊断实验室中的复杂分析程序与体外诊断医疗器械法规。 - Suppr

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超能文献

Complex analytical procedures in diagnostic laboratories and the IVDR.

作者信息

Vogeser Michael, Brüggemann Monika

机构信息

Institute of Laboratory Medicine, University Hospital, LMU Munich, Munich, Germany.

Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany.

出版信息

Clin Chem Lab Med. 2020 Dec 11;59(3):457-458. doi: 10.1515/cclm-2020-1775.

DOI:10.1515/cclm-2020-1775

PMID:33554564

Abstract

摘要

相似文献

Complex analytical procedures in diagnostic laboratories and the IVDR.诊断实验室中的复杂分析程序与体外诊断医疗器械法规。

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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European -Diagnostics Regulation.ISO 15189是确保高质量生产符合欧洲诊断法规要求的内部使用的实验室自建检测项目的充分手段。

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Implementing Regulation (EU) 2017/746 of 5 April 2017 on In vitro Diagnostic Medical Devices (IVDR) in Medical Laboratories, especially in Ophthalmopathology.2017 年 4 月 5 日关于体外诊断医疗器械（IVDR）在医学实验室中的实施条例（EU）2017/746，特别是在眼病理领域。

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Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).实验室自建检测方法：符合国际最新技术水平及欧盟法规（EU）2017/746（欧盟体外诊断医疗器械法规）的监管策略设计

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The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care.2017/746 号新体外诊断法规：比利时一家大型大学医院实验室的案例研究表明，有必要明确实验室在使用实验室自建检测以改善患者护理方面的自由度。

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Implementation of the new EUR IVD regulation and relation with ISO15189 accreditation: Guidance is urgently required for haemostasis testing.实施新的欧盟体外诊断医疗器械法规与 ISO15189 认可的关系：血栓与止血检验急需指导。

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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).德国医学科学学会（AWMF）特别委员会关于仅在根据法规 (EU) 2017/746（IVDR）在欧盟境内设立的医疗机构中制造和使用的体外诊断医疗器械的咨询意见。

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In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)?体外诊断医疗器械法规（IVDR）：实验室自建检测方法（LDT）的终结？

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Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices.欧洲和德国医疗器械法规中的病理学：体外诊断医疗器械的操作、使用和内部制造。

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Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like.临时监管调整和 2019 年冠状病毒病（COVID-19）PCR 标签更新研究表明，美国食品和药物管理局（FDA）对实验室开发的检测的监管可能是什么样子。

J Mol Diagn. 2021 Oct;23(10):1207-1217. doi: 10.1016/j.jmoldx.2021.07.011. Epub 2021 Sep 16.

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The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories.欧盟体外诊断医疗器械新法规：对诊断实验室的影响及准备行动

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