<p>ISO 10993-1:2009 describes:</p>
<ul>
<li>the general principles governing the biological evaluation of medical devices within a risk management process;</li>
<li>the general categorization of devices based on the nature and duration of their contact with the body;</li>
<li>the evaluation of existing relevant data from all sources;</li>
<li>the identification of gaps in the available data set on the basis of a risk analysis;</li>
<li>the identification of additional data sets necessary to analyse the biological safety of the medical device;</li>
<li>the assessment of the biological safety of the medical device.</li>
</ul>
Registration number (WIID)
44908
Scope
<p>ISO 10993-1:2009 describes:</p>
<ul>
<li>the general principles governing the biological evaluation of medical devices within a risk management process;</li>
<li>the general categorization of devices based on the nature and duration of their contact with the body;</li>
<li>the evaluation of existing relevant data from all sources;</li>
<li>the identification of gaps in the available data set on the basis of a risk analysis;</li>
<li>the identification of additional data sets necessary to analyse the biological safety of the medical device;</li>
<li>the assessment of the biological safety of the medical device.</li>
</ul>
