GB/T 19703-2005 in English

《GB/T 19703-2005体外诊断医疗器械 生物源性样品中量的测量 参考物质的说明》由TC136（全国医用临床检验实验室和体外诊断系统标准化技术委员会）归口，主管部门为国家药品监督管理局
本标准规定了参考物质说明的要求和格式。本标准适用于较高计量学水平的参考物质，这些参考物质可以被分类为一级测量标准和二级测量标准，其作用是作为参考测量程序的校准品或控制物质。本标准不适用于作为体外诊断测量系统组成部分的参考物质。本标准同时也提供了为确定数值而收集基础数据的规程，以及出具所赋值的方式。本标准还规定了证书格式。本标准不适用于这些参考物质的生产过程。

Scope

This standard specifies the requirements and format for the description of reference substances. This standard applies to reference materials at a higher metrological level, which can be classified as primary measurement standards and secondary measurement standards, and are used as calibrators or control substances for reference measurement procedures. This standard does not apply to reference substances that are part of in vitro diagnostic measurement systems. This International Standard also provides the procedure for collecting the basic data for determining the value and the method for issuing the assigned value. This standard also specifies the certificate format. This standard does not apply to the production process of these reference materials.