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This International Standard specifies requirements for determining commutability of a CRM (3.4)for which commutability (3.7) with clinical samples (3.6) is required, and the content of the supporting documentation. This standard is applicable to a commutable (3.7) CRM (3.4) intended for use as a secondary calibrator (3.32) or international conventional calibrator (3.13) in the m.3 position of calibration hierarchies described in ISO 17511 and that comply with the requirements of ISO 15194. This Standard is also applicable to a CRM (3.4) used as a trueness control (3.33) for an end-user measurement procedure (MP) (3.19).
This standard applies primarily to commutable secondary calibrator (3.32) CRMs (3.4) 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. For qualitative or visually interpreted measurement procedures, this document may serve as a conceptual framework, but additional criteria may apply.
When a commutable secondary calibrator (3.32) CRM (3.4) includes multiple measurands, this Standard is applied to each of the measurands present in the CRM (3.4).
This standard does not apply to a primary reference material (3.25) that consists of a defined high-purity analyte (3.1).
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