In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
体外诊断医疗器械——生物来源样品数量的测量——认证标准物质的要求和支持文件的内容
发布日期:
2009-04-28
ISO 15194:2009规定了认证标准物质的要求及其支持文件的内容,以便根据ISO 17511将其视为更高的计量顺序。本标准适用于可归类为一级测量标准、二级测量标准和国际常规校准器的认证标准物质,这些标准物质既可作为校准器,也可作为真度控制材料。ISO 15194:2009还提供了关于如何收集数据以确定值以及如何表示指定值及其测量不确定度的要求。
ISO 15194:2009适用于具有微分或合理量赋值的认证标准物质。附录A提供了有关标称特性和序数的信息。
ISO 15194:2009不适用于作为体外诊断测量系统一部分的参考材料,尽管许多元素可能有用。
ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.