Kuwa Katsuhiko
Graduate School of Comprehensive Human Sciences/Institute of Clinical Medicine, University of Tsukuba, Tsukuba, 305-8575.
Rinsho Byori. 2005 Jun;53(6):531-9.
From the work at ISO/TC212 (Clinical laboratory testing and in vitro diagnostic test systems), the international standards on medical laboratories--particular requirements for quality and competence and reference materials were issued. The accreditation of clinical laboratory was started using ISO 15189. Furthermore, on setting and usage of reference materials were constituted with compatibility global harmonization by newly organizing JCTLM (Joint Committee on Traceability in Laboratory Medicine). As the results, the work of the standardization based on reliability such as validation of reagent's kits and the measured values and uncertainty evaluation would be internationally advanced.
源自ISO/TC212(临床实验室检测和体外诊断试验系统)的工作,发布了关于医学实验室的国际标准——质量和能力的特殊要求以及参考物质。临床实验室认可开始采用ISO 15189。此外,通过新组建的JCTLM(医学实验室溯源联合委员会)对参考物质的定值和使用进行全球协调一致。结果,基于可靠性的标准化工作,如试剂盒和测量值的验证以及不确定度评估等将在国际上取得进展。