ISO 17511 PDF

ISO 17511 PDF

Overview of ISO for ‘Biologicals’. (R.D. ). R. Dybkaer. Department of Standardization in Laboratory Medicine. Copenhagen Hospital. ISO E In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators. ISO. First edition. In vitro diagnostic medical devices —. Measurement of quantities in biological samples — Metrological traceability.

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Discover all the features. Please first verify your email before subscribing to alerts. Some text some message. Purpose This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify ios of measurement. Register Now for free. As the voice of the U. View all the features Register Now for free.

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This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity. The most powerful web application for CE-Marking Your declarations of conformity online. In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials ISO Already Subscribed to this document. 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.

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This European Isk 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. 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.

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