<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for vascular stents (see ISO 25539-2).</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Guidance on the selection of balloon materials is given in Annex G.</span></p>
Registration number (WIID)
76495
Scope
<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for vascular stents (see ISO 25539-2).</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Guidance on the selection of balloon materials is given in Annex G.</span></p>
