Cart
0
Product
Products
(empty)
No products
To be determined
Shipping
$0.00
Total
Product successfully added to your shopping cart
Quantity
Total
There are 0 items in your cart.
There is 1 item in your cart.
Total products
Total shipping
To be determined
Total
Sale!
View larger
View larger
AAMI 14708-5
New product
AAMI 14708-5 2010 Edition, January 1, 2010 Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
More info
Description / Abstract:
This part of ISO 14708 specifies requirements for safety and
performance of active implantable circulatory support devices. It
is not applicable to extracorporeal perfusion devices,
cardiomyoplasty, heart restraint devices and counter-pulsation
devices, such as extra- or intra-aortic balloon pumps.
This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.
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.
This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.
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.