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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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, declarations of conformity, amended declarations View all the features.

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Already Subscribed to this document. This option will restart the initial tutorial. Register Now for free. 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. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.

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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? Add to Alert PDF.

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Subscription pricing is determined by: This standard is also available to be included in Standards Subscriptions. Some text some message. If the document is revised or amended, you will be notified by email. 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.

Need more than one copy? Your Alert Profile lists the documents that will be monitored. 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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