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ISO 15189:2012与临床实验室设备管理 被引量:7

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摘要 临床实验室有效的设备管理对于实验室正常运转和检验质量提高至关重要。ISO 15189:2012也对实验室设备做出了相应要求。根据ISO 15189:2012中的要求并综合有关文献,本文从设备验收试验、设备使用说明、设备校准和计量学溯源、设备维护与维修、设备不良事件报告、设备退役和设备记录等方面对设备管理提出建议,希望对临床实验室有所帮助。
机构地区 北京医院
出处 《临床检验杂志》 CAS CSCD 2015年第2期137-139,共3页 Chinese Journal of Clinical Laboratory Science
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参考文献10

  • 1ISO 15189. Medical laboratories-Requirements for quality and compe- tence [ S ]. International Organization for Standardization, 2012.
  • 2CLSI document EP15-A2. User verification of performance for preci- sion and trueness [ S ]. Clinical and Laboratory Standards Institute, 2006.
  • 3CLSI/NCCLS document EP05-A2. Evaluation of precision perform- ance of quantitative measurement methods [ S ]. National Committee for Clinical Laboratory Standards, 2004.
  • 4CLSI/NCCLS document EPO6-A. Evaluation of the linearity of quan- titative measurement procedures: a statistical approach [ S ]. National Committee for Clinical Laboratory Standards, 2003.
  • 5CLSI document EPO9-A2-IR. Method comparison and bias estimation using patient samples[ S]. Clinical and Laboratory Standards Institu- te, 2010.
  • 6CLSI document C28-A3c. Defining, establishing, and verifying refer- ence intervals in the clinical laboratory [ S ]. Clinical and Laboratory Standards Institute, 2010.
  • 7CLSI document H26-A2. Validation, verification, and quality assur- ance of automated hematology analyzers [ S ]. Clinical and laboratory standards institute, 2010.
  • 8CLSI document GP02-AS. Laboratory documents: development and control[ S ]. Clinical and Laboratory Standards Institute, 2006.
  • 9CLSI document GP21-A3. Training and competence assessment [ S ]. Clinical and Laboratory Standards Institute, 2009.
  • 10CLSI document EP18-A2. Risk management techniques to identify and control laboratory error sources [ S ]. Clinical and Laboratory Standards Institute, 2009.

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