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<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>
Reģistrācijas numurs (WIID)
39751
Darbības sfēra
<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>
