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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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. Please first log in with a verified email before subscribing to alerts.

The calibrators and control materials iwo those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. Discover all the features.

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Already Subscribed to this document. 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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Last Official Journal reference 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, 1511 to be used together with, in vitro diagnostic medical devices. Add to Alert PDF.

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You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server. Some text some message. In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials Jso The most powerful web application for CE-Marking Your declarations of conformity online.

If the document is revised or amended, you will be notified by email. This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity. This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of isl This software allows you to compose iiso 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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