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.
Status: PublishedPublication date: 2004-07
Edition: 1Number of pages: 10
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
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