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In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
| 분야 | ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems |
|---|---|
| 적용범위 | 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). |
| 국제분류(ICS)코드 | 11.100.10 : 체외진단용 시험 시스템 |
| 페이지수 | 23 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 17511:2020 | In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples | 2020-04-24 | 표준 |
| 2 | ISO 17511:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials | 2003-08-22 | 구판 |
관련상품이 존재하지 않습니다.
BS EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices. 상세보기
BS EN ISO 18113-1:2011 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements. 상세보기
BS EN ISO 18113-2:2011 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use. 상세보기
BS EN ISO 23640:2015 - In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents. 상세보기
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