<p>ISO 15198:2004 describes a process for manufacturers of <i>in vitro</i> 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 <i>in vitro </i>diagnostic medical devices.</p>
Registration number (WIID)
39751
Scope
<p>ISO 15198:2004 describes a process for manufacturers of <i>in vitro</i> 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 <i>in vitro </i>diagnostic medical devices.</p>
