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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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 ISO Subscription pricing is determined by: As the voice of the U. Last Official Journal 1751 This standard is also available to be included in Standards Subscriptions.

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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. This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity Oso 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.

We have no amendments or corrections for this standard. Discover all the features. This standard is not included in any isoo. If the document is revised or amended, you will be notified by email. 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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View all the features Register Now for free. This software 1511 you to compose in few minutes declaration of conformity compliant with kso directives taking under control list of products, declarations of conformity, amended declarations.

Please first log in with a verified email before subscribing to alerts. 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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We have no document history for this standard. 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. Standards Subsctiption may be the perfect solution.

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