<p>ISO 14708-2:2005 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias (cardiac pacemakers).</p>
<p>The tests that are specified in ISO 14708-2:2005 are type tests, and are to be carried out on samples of a device to show compliance.</p>
<p>ISO 14708-2:2005 is also applicable to some non-implantable parts and accessories of the devices. The device that is commonly referred to as an active implantable medical device may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.</p>
<p>The characteristics of the implantable pulse generator or lead are to be determined by either the appropriate method detailed in ISO 14708-2:2005 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in ISO 14708-2:2005 is applicable.</p>
Registration number (WIID)
31508
Scope
<p>ISO 14708-2:2005 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias (cardiac pacemakers).</p>
<p>The tests that are specified in ISO 14708-2:2005 are type tests, and are to be carried out on samples of a device to show compliance.</p>
<p>ISO 14708-2:2005 is also applicable to some non-implantable parts and accessories of the devices. The device that is commonly referred to as an active implantable medical device may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.</p>
<p>The characteristics of the implantable pulse generator or lead are to be determined by either the appropriate method detailed in ISO 14708-2:2005 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in ISO 14708-2:2005 is applicable.</p>
