<p>ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood.</p>
<p>It describes</p>
<ol><li>a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,</li><li>the fundamental principles governing the evaluation of the interaction of devices with blood,</li><li>the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.</li></ol>
<p>Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. </p>
Registration number (WIID)
32086
Scope
<p>ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood.</p>
<p>It describes</p>
<ol><li>a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,</li><li>the fundamental principles governing the evaluation of the interaction of devices with blood,</li><li>the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.</li></ol>
<p>Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. </p>
