ComplianceOnline

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices


Document Number: ISO 14708-5:2010
File Size: 374 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $0.00
Product Details

ISO 14708-5:2010 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.

ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.

Other parts of this product are listed below:

Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading
Loading...