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<p><span lang="EN-GB">This document specifies strategies for risk estimation and evaluation of biological harms with respect to:</span></p>
<ul>
<li><span lang="EN-GB">genotoxicity;</span></li>
<li><span lang="EN-GB">carcinogenicity;</span></li>
<li><span lang="EN-GB">reproductive toxicity; and</span></li>
<li><span lang="EN-GB">developmental toxicity.</span></li>
</ul>
<p><span lang="EN-GB">This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established. </span></p>
<p><span lang="EN-GB">This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.</span></p>
<p><span lang="EN-GB">NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.</span></p>
Reģistrācijas numurs (WIID)
88199
Darbības sfēra
<p><span lang="EN-GB">This document specifies strategies for risk estimation and evaluation of biological harms with respect to:</span></p>
<ul>
<li><span lang="EN-GB">genotoxicity;</span></li>
<li><span lang="EN-GB">carcinogenicity;</span></li>
<li><span lang="EN-GB">reproductive toxicity; and</span></li>
<li><span lang="EN-GB">developmental toxicity.</span></li>
</ul>
<p><span lang="EN-GB">This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established. </span></p>
<p><span lang="EN-GB">This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.</span></p>
<p><span lang="EN-GB">NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.</span></p>
