ISO 17511:2003规定了如何确保分配给校准器和控制材料的值的计量可追溯性，以确定或验证测量的真实性。校准器和控制材料是制造商提供的体外诊断医疗设备的一部分或与之配合使用的那些。 通过国际商定的参考测量系统或国际认可的常规参考测量系统分配的外部质量评估（调查）样本，具有可靠的可交换性，属于ISO 17511:2003的范围。 ISO 17511:2003不适用于不具有指定值的控制材料，仅用于评估测量程序的精度，重复性或重现性（精密控制材料）;控制材料旨在进行内部质量控制目的，并提供间隔建议的可接受值，每个间隔通过实验室间一致性相对于一个指定的测量程序获得，限制值不是计量可追溯的;两个测量程序的结果在相同的计量级别之间的相关性，据称测量相同的数量，因为这样

ISO 17511:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of ISO 17511:2003. ISO 17511:2003 is not applicable to control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; correlation between results of two measurement procedures at the same metrological level, purporting to measure the same quantity, because such "horizontal" correlation does not provide metrological traceability; calibration derived from correlation between the results of two measurement procedures at different metrological levels, but with quantities having analytes of different characteristics; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; and properties involving nominal scales, i.e. where no magnitude is involved (e.g. identification of blood cells).