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<p>This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.</p>
<p>NOTE The device that is commonly referred to as an active implantable medical device can 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 main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.</p>
<p>The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.</p>
<p>Included in the scope of this document are:</p>
<p>— ventricular assist devices (VAD), left or right heart support;</p>
<p>— total artificial hearts (TAH);</p>
<p>— biventricular assist devices (biVAD);</p>
<p>— percutaneous assist devices;</p>
<p>— paediatric assist devices.</p>
Reģistrācijas numurs (WIID)
69898
Darbības sfēra
<p>This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.</p>
<p>NOTE The device that is commonly referred to as an active implantable medical device can 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 main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.</p>
<p>The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.</p>
<p>Included in the scope of this document are:</p>
<p>— ventricular assist devices (VAD), left or right heart support;</p>
<p>— total artificial hearts (TAH);</p>
<p>— biventricular assist devices (biVAD);</p>
<p>— percutaneous assist devices;</p>
<p>— paediatric assist devices.</p>
