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In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials

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분야	ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems
적용범위	ISO 15194:2002 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 procedures. ISO 15194:2002 is not applicable to reference materials that are parts of an in vitro diagnostic measuring system. ISO 15194:2002 also provides instructions on how to collect basic data for value assignment and how to present the assigned value as well as specifies the format for a certificate. ISO 15194:2002 is not applicable to the production of the reference materials.
국제분류(ICS)코드	11.100.10 : 체외진단용 시험 시스템
페이지수	14
Edition	1

No.	표준번호	표준명	발행일	상태
1	ISO 15194:2009	In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation	2009-04-28	표준
2	ISO 15194:2002	In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials	2002-10-10	구판