临床检验量值溯源与不确定度评定培训.pptVIP

临床检验量值溯源与不确定度评定 陈文祥 卫生部临床检验中心 卫生部北京医院老年医学研究所 2008.2.26，北京;关于临床检验量值溯源(1);欧盟体外诊断器具 (Directive 98/79/EC) 校准物和/或质控物的定值，必须通过已有的高一级的参考测量程序和/或参考物质，保证其溯源性 The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurements and/or available reference materials of higher order SCHEDULED IMPLEMENTATION First IVD product with CE Mark may be placed from June 2000 onwards All new IVD products must have mark by December 2003 Existing IVD products may be sold without the CE mark until December 2005;关于临床检验量值溯源(2);关于临床检验量值溯源(3);关于临床检验量值溯源(4);临床检验