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<p>ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).<sup>[</sup><sup>1?9</sup><sup>]</sup> It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.<sup>[</sup><sup>11</sup><sup>]</sup> It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.</p>
Reģistrācijas numurs (WIID)
61830
Darbības sfēra
<p>ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).<sup>[</sup><sup>1?9</sup><sup>]</sup> It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.<sup>[</sup><sup>11</sup><sup>]</sup> It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.</p>
