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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EN ISO standard – CE Marking assistant

Please first log in with a verified email before subscribing to alerts. Add to Alert PDF. Request for a new iiso Bug in the software Request explaning or help Other. As the voice of the U. 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 taking under control list of products, declarations of conformity, amended declarations.

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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. Please first verify 175511 email before subscribing to alerts.

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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. If the document is revised or amended, you will be notified by email. The most powerful web application for CE-Marking Your declarations of conformity online.

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1751 Do you want to proceed? Control materials that do not have an 17511 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. 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 standard is not included in any packages. In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials ISO Subscription pricing is determined by: 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.

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