IJJF1353—2012血液透析装置校准规范CalibrationSpecificationforHeniodialysisEquipmentIIJJF1353—2012目录1范围....................................................................(1)2引用文件..................................................................(1)3术语和定义..............................................................(1)4.1血液透析..............................................................(1)3.2透析..................................................................(1)3.3透析液................................................................(1)3.4血液透析器............................................................(1)3.5血液滤过..............................................................(1)3.6电导率................................................................(1)4.7血液净化..............................................................(1)3.8血液透析装置..........................................................(1)3.9抗凝泵................................................................(2)4概述....................................................................(2)5计量特性................................................................(2)6校准条件................................................................(3)7.1环境条件..............................................................(3)6.2校准用设备及其他设备....................................................(3)7校准项目和校准方法........................................................(3)8.1外观及工作正常性检查..................................................(3)8.2校准前准备............................................................(4)8.3透析液电导率示值误差..................................................(4)8.4透析液温度示值误差和超温报警误差......................................(4)8.5静(动)脉压监控示值误差和静(动)脉压监控报警误差....................(4)8.6透析液压力监控示值误差和透析液压力监控报警误差........................(5)8.7透析液流量监控示值误差................................................(5)8.8抗凝泵注入流量监控示值误差............................................(6)7.9透析液PH监控示值误差.................................................(6)7.10称重计示值误差......................................................(7)7.11脱水量示值误差......................................................(7)8校准结果表达..............................................................(7)8.1校准记录..............................................................(7)9.2校准结果的处理........................................................(7)9复校时间间隔.............................................................(8)∏JJF1353—2012附录A血液透析装置校准原始记录格式.......................................(9)附录B血液透析装置校准证书(内页)格式........................................(14)附录C血液透析装置流量监控示值误差的测量不确定度评定.........................(15)1JJF1353—2012血液透析装置校准规范1范围本校准规范规定了血液透析装置的计量特性、校准条件、校准方法.适用于新制造、使用中及修理后的血液透析装置的计量性能校准,不适用于连续性肾脏替代治疗(CRRT)设备的校准。2引用文件GB9706.22003医用电气设备第2-16部分:血液透析、血液透析滤过和血液滤过设备的安全专用要求GB13074-2009血液净化术语GB/T14710-2009医用电器环境要求及试验方法YY0054—2010血液透析设备凡是注日期的引用...