Dumontet M, Fuss-Ohlen I, Beaudeux J-L, Perrin A, Vassault A, Giroud C, Le Moel G, Guitel F, Ziani S, Zerah S, Robineau S, Braconnier F
CH René Dubos, Pontoise.
Ann Biol Clin (Paris). 2004 Jan-Feb;62(1):121-5.
Clinical laboratories shall have a perfect control of "in vitro diagnostic medical devices" to ensure the quality of their analytical results. This introductory presentation to a serie of documents of recommendations tackles the different standards of metrology concerning the requirements to reference materials, metrological traceability, metrological confirmation, management of measurement as well as uncertainty of measurement. The standards concerning clinical laboratories are then succinctly described.
临床实验室应完善对“体外诊断医疗器械”的控制，以确保其分析结果的质量。本系列推荐文件的介绍性说明涉及计量的不同标准，包括参考物质要求、计量溯源性、计量确认、测量管理以及测量不确定度。随后简要描述了与临床实验室相关的标准。
