Informējam, ka Sistēma pielāgota darbam ar interneta pārlūkprogrammu Internet Explorer (8. un jaunākām versijām) un Mozilla Firefox (3.6 un jaunākām versijām).
Izmantojot citu interneta pārlūkprogrammu, brīdinām, ka Sistēmas funkcionalitāte var tikt traucēta.
<p><span lang="EN-GB">This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices that have electrogram sensing and pacing functions with or without defibrillation capability. This document includes requirements for the connector portion of an implantable lead and for the mating connector cavity attached to an implantable pulse generator. Key dimensions and performance requirements are specified together with appropriate test methods.</span></p>
<p><span lang="EN-GB">This document establishes two types of connector assembly with their configurations, which are not intended to be interchangeable: </span></p>
<ul>
<li><span lang="EN-GB">a high-voltage connector: a connector that can have either </span></li>
<li><span lang="EN-GB">two low-voltage contacts combined with one or two high-voltage contacts, or </span></li>
<li><span lang="EN-GB">only two high-voltage contacts;</span></li>
<li><span lang="EN-GB">a “low-voltage only connector”: a connector that has either three or four low-voltage contacts.</span></li>
</ul>
<p><span lang="EN-GB">This document specifies a dimensional lockout feature that prevents the low-voltage contacts of the lead connectors from contacting the high-voltage contacts of high-voltage connector cavities.</span></p>
<p><span lang="EN-GB">This document does not replace or provide alternatives for unipolar or bipolar connector International Standards that currently exist (such as ISO 11318</span>[2]<span lang="EN-GB"> and ISO 5841-3</span>[1]<span lang="EN-GB">).</span></p>
<p><span lang="EN-GB">This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V or systems with an electric flow greater than 50 A.</span></p>
<p><span lang="EN-GB">This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing electrogram sensing or defibrillation functions.</span></p>
<p><span lang="EN-GB">This document does not specify all connector features and it does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.</span></p>
<p><span lang="EN-GB">This document does not include requirements for accessories or adaptors used with four-pole connectors. Refer to </span>Annex P<span lang="EN-GB"> for more information on connector-related products.</span></p>
<p><span lang="EN-GB">NOTE 1 The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.</span></p>
<p><span lang="EN-GB">NOTE 2 Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.</span></p>
Reģistrācijas numurs (WIID)
86332
Darbības sfēra
<p><span lang="EN-GB">This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices that have electrogram sensing and pacing functions with or without defibrillation capability. This document includes requirements for the connector portion of an implantable lead and for the mating connector cavity attached to an implantable pulse generator. Key dimensions and performance requirements are specified together with appropriate test methods.</span></p>
<p><span lang="EN-GB">This document establishes two types of connector assembly with their configurations, which are not intended to be interchangeable: </span></p>
<ul>
<li><span lang="EN-GB">a high-voltage connector: a connector that can have either </span></li>
<li><span lang="EN-GB">two low-voltage contacts combined with one or two high-voltage contacts, or </span></li>
<li><span lang="EN-GB">only two high-voltage contacts;</span></li>
<li><span lang="EN-GB">a “low-voltage only connector”: a connector that has either three or four low-voltage contacts.</span></li>
</ul>
<p><span lang="EN-GB">This document specifies a dimensional lockout feature that prevents the low-voltage contacts of the lead connectors from contacting the high-voltage contacts of high-voltage connector cavities.</span></p>
<p><span lang="EN-GB">This document does not replace or provide alternatives for unipolar or bipolar connector International Standards that currently exist (such as ISO 11318</span>[2]<span lang="EN-GB"> and ISO 5841-3</span>[1]<span lang="EN-GB">).</span></p>
<p><span lang="EN-GB">This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V or systems with an electric flow greater than 50 A.</span></p>
<p><span lang="EN-GB">This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing electrogram sensing or defibrillation functions.</span></p>
<p><span lang="EN-GB">This document does not specify all connector features and it does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.</span></p>
<p><span lang="EN-GB">This document does not include requirements for accessories or adaptors used with four-pole connectors. Refer to </span>Annex P<span lang="EN-GB"> for more information on connector-related products.</span></p>
<p><span lang="EN-GB">NOTE 1 The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.</span></p>
<p><span lang="EN-GB">NOTE 2 Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.</span></p>
