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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We have no document history for this standard. 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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Standards Subsctiption may be the perfect solution. 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 of conformity compliant with applicable directives taking under control list of products, iiso of conformity, amended declarations View all the features.

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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 We have no amendments or corrections for this standard.

You may delete a document from your Alert Profile at any time. Add to Alert PDF. 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.

You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server. In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials ISO This option will restart the initial tutorial.

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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.

Please first log in with a verified email before subscribing to alerts. This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations.

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