ISO 15194-2002
实验室条件下医用诊断装置.生物原始试样中数量值的测量.标准物质的描述

In vitro diagnostic systems - Measurement of quantities in samples of biological origin - Description of reference materials


标准号
ISO 15194-2002
发布日期
2002-10
实施日期
废止日期
中国标准分类号
C30
国际标准分类号
11.100.10
发布单位
IX-ISO
代替标准
ISO 15194-2009
适用范围
This European Standard specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement pro-cedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This European Standard also provides instructions on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate. This European Standard is not applicable to the production of the reference materials.

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