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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In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials ISO 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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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.

We have no amendments or corrections for this standard. You may delete a document from your Alert Profile at any time. View all the features Register Now for free. Register Now for free. This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity. Some text some message.

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The calibrators and control materials are those provided iwo the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The most powerful web application for CE-Marking Your declarations of conformity online. Your Alert Profile lists the documents that will be monitored. Add to Alert PDF.

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DO Test Plan Generator. Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards. This software allows you to compose in few minutes declaration of conformity compliant with applicable directives io under control list of products, declarations of conformity, amended declarations.

Do you want to proceed? As the voice of the U. 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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If the document is revised or amended, you will be notified by email. This standard is also available to be included in Standards Subscriptions. 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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