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CEN - EN 13612

Performance Evaluation of in Vitro Diagnostic Medical Devices

inactive
Organization: CEN
Publication Date: 1 March 2002
Status: inactive
Page Count: 18
ICS Code (Laboratory medicine): 11.100

Document History

EN 13612
March 1, 2002
Performance evaluation of in vitro diagnostic medical devices
A description is not available for this item.
EN 13612
March 1, 2002
Performance Evaluation of in Vitro Diagnostic Medical Devices
A description is not available for this item.

References

This document is referenced by:
ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by ISO on May 15, 2013
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
This document is referenced by:
DIN EN ISO 18113-1 - In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009); Deutsche Fassung EN ISO 18113-1:2011
Published by DIN on January 1, 2013
Dieser Teil von ISO 18113 definiert Konzepte, stellt allgemeine Prinzipien auf und legt wesentliche Anforderungen an die durch den Hersteller von In-vitro-Diagnostika bereitzustellenden Informationen...
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