ISO 17511 PDF

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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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Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards. 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.

Last Official Journal reference This option will restart the initial tutorial. 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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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. Do you want to proceed?

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Discover all the features. This software allows you to compose in few minutes declaration of conformity 177511 with applicable directives taking under control list of products, declarations of conformity, amended declarations. In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials ISO Purpose 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.

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Already Subscribed to this document. This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity This software allows you to compose in few minutes declaration 17511 conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations View all the features.