Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.
This document is available in electronic only.
Date of Publication: July 1, 2004
Order Code PDF: ISO15198E
Order Code Print: print not available
ISO 15198:2004 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.