ISO 17511 PDF

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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 standard is not included in any packages. Request for a new functionality Bug in the software Request explaning or help Other. 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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The most powerful web application for CE-Marking Your declarations of conformity online. View all the features Register Now for free. 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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Standards Subsctiption may be the perfect solution. 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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This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of isso, amended declarations. In vitro diagnostic medical devices – Measurement of quantities in biological samples 175511 Metrological traceability of values assigned to calibrators and control materials ISO 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.

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