ISO 15197:2013 pdf free

ISO 15197:2013 pdf free.In vitro diagnostic test systems
property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty
Note 1 to entry: For this definition, a reference can be a definition of a measurement unit through its practical realization, or a measurement procedure including the measurement unit for a nonordinal quantity, or a measurement standard.
Note 2 toentry: Metrological traceability requires an established calibration hierarchy. The sequence of measurement standards and calibrations that is used to relate a measurement result to a reference is called a traceability chain.A metrological traceability chain is used to establish metrological traceability of a measurement result, including calibrator values. See ISO 17511 for examples of traceability chains pertaining to IVD medical devices.
Note 3 to entry: Specification of the stated reference must include the time at which this reference was used in establishing the calibration hierarchy, along with any other relevant metrological information about the reference,such as when the first calibration in the calibration hierarchy was performed.
Note 4 to entry: For measurements with more than one input quantity in the measurement model, each of the quantity values should itself be metrologically traceable and the calibration hierarchy involved can form a branched structure or a network. The effort involved in establishing metrological traceability for each input quantity should be commensurate with its relative contribution to the measurement result.
Note 5 to entry: A comparison between two measurement standards can be viewed as a calibration if the comparison is used to check and, if necessary, correct the quantity value and measurement uncertainty attributed to one of the measurement standards.
Note 6 to entry: The abbreviated term traceability is sometimes used to mean metrological traceability as well as other concepts, such as sample traceability or document traceability or instrument traceability or material traceability, where the history (trace) of an item is meant. Therefore, the full term of metrological traceability is preferred if there is any chance of confusion.
Note 7 to entry: Adapted from ISO/IEC Guide 99:2007, definition 2.41.ISO 15197 pdf download.