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加强医学实验室技术能力 做好实验室认可 被引量:1

Reinforcing the technical competence and laboratory accreditation according to the 3rd edition of ISO15189: 2012
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摘要 文中扼要讨论了国际标准化组织(International Standardization Organization,ISO)15189-2012中"5技术要求"对测量过程3个重要要求,即:"5.3.1.4设备校准和计量溯源;5.5.1.3(2)测量程序的确认;5.5.1.4测量定量值的测量不确定度。"我国医学实验室如能达到这些要求,将极大加强技术能力,并保证测量结果的可靠性。希望我国认可组织能制定相应的导则或技术报告,也希望中华临床实验室管理电子杂志能多发表相关文章,以引起同行的参与与关注。 Three important requirements are stressed in 5 technical requirements'of ISO 15189 (2012) 3rd edition as follows: 5.3.1.4 Equipment calibration and metrology traceability; 5.5.1.3(2) Validation of examination procedure; and 5.5.1.4 Measurement uncertainty of measured quantity values. Chinese medical laboratories will prompt their technical competence and assure the reliability of measurement results once they meet these requirements. Guidelines and technical reports shall be prepared by Chinese Laboratory Accreditation Organization and more papers about these topics should be published on this journal to appeal for the attention and participation of laboratory professionals.
作者 杨振华
出处 《中华临床实验室管理电子杂志》 2013年第1期12-14,共3页 Chinese Journal of Clinical Laboratory Management(Electronic Edition)
关键词 溯源 确认 测量 不确定度 Traceability Validation Measurement Uncertainty
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参考文献8

  • 1Clinical and Laboratory Standards Institute. Metrology traceability and its implementation,a report[S].Wayne:CLSI,2006.
  • 2International Organization for Standardization,2012 ISO 15189. Medical laboratory-particular requirements on quality and competence[M].Geneva:ISO,2012.
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