DIN EN ISO 17511:2021 Edition

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In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Published By	Publication Date	Number of Pages
DIN	2021-11	68

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Categories: 11.100.10 - In vitro diagnostic test systems, DIN

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Description

This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement, and provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. 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, are outside the scope of this European Standard.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2021-11
Pages Count	68
Language	Germany
Descriptors	Accuracy, Biochemicals, Biological materials, Calibration materials, Calibrator, CE marking, Characterisations, Characteristics, Check material, Chemical analysis and testing, Classification, Classification systems, Definitions, Descriptions, Diagnosis, Diagnosis (medical), Diagnostic equipment, Evaluations, Human medicine, In vitro, In-vitro diagnostic, Laboratories, Laboratory medicine, Lists, Measured value, Measurement, Measuring systems, Measuring techniques, Medical devices, Medical sciences, Metrology, Recirculation, Samples, Size, Specification (approval), Systemology, Traceability, Verification, Wear-quantity, Medical products
File Size	4.0 MB
ICS Codes	11.100.10 - In vitro diagnostic test systems

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DIN EN ISO 17511:2021 Edition

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