3European Union. Directive 98/79/EC of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices.Official Journal of the European Communities, 1998, L331 : 1-37.
4International Organization for Standardization. In vitro diagnostic medical devices-measurement of quantities in samples of biological originmetrological traceability of values assigned to calibrators and control materials. ISO/DIS 17511, International Organization for Standardization,Geneva,2000.
5International Organization for standardization. In vitro diagnostic medical devices-measurement of quantities in samples of biological originmetrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials. ISO/DIS 18153,International Organization for Standardization, Geneva, 2000.
6International Organization for Standardization. General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025,International organization for standardization, Geneva, 1999.
7International Organization for Standardization. Quality management i0n the medical laboratory. ISO/FDIS 15189, International Organization for Standardization, Geneva, 2000.
8Siekmann L. Traceability of calibration for IVD industry: Process for eredentialing reference materials, reference methods and reference laboratories in europe. In: proceedings of the workshop on measurement traceability for clinical laboratory testing and in vitro diagnostic test systems. National Institute of Standards and Technology, Gaithersburg MD, 2000. 85-101.
9Eckfeldt JH. History of reference systema in clinical measurements. In :proceedings of the workshop on measurement traceability for clinical laboratory testing and in vitro diagnostic test systems. National institute of standards and Technology: Gaithersburg MD, 2000. 161-172.
10Paul W D, Michael D A, Allison S A, et al. C3d of complement as a molecular adjuvant:bridging innate acquired immunity[ J]. Science, 1996,271(5247) :348-350.
