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prEN ISO 15194

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)

General information
Draft
Base Documents
ISO/DIS 15194; prEN ISO 15194
Directives or regulations
None

Standard history

Status
Date
Type
Name
06.11.2009
Main
This standard specifies requirements for producers of CRMs of higher metrological order and the content of their supporting documentation that comply with the requirements of ISO 17511 and the calibration hierarchies described therein. It is applicable to CRMs intended for use as either primary reference materials, secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. Requirements for determining the certified value of a CRM, including evaluation and reporting of the assigned uncertainty, are specified.
This standard applies primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in the scope of ISO 17511:2020. Annex A provides information on CRMs for qualitative nominal properties and ordinal quantities, to provide guidance on important quality attributes for such CRMs, whilst recognizing that they are not within the metrological traceability schemes described in ISO 17511:2020.
When a CRM includes multiple measurands, this Standard is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this Standard will also be useful for RMs that do not comply with the full metrological requirements of CRMs. For example, this International Standard does not apply to a RM created by IVD MD manufacturers for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content may be useful in assessing its performance.
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