BS ISO 15198:2004

Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer. | Status: Current, Proposed for withdrawal

1 Scope This International Standard 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. This International Standard applies to all in vitro diagnostic medical devices.