Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2010, IDT)
This Malaysian Standard 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 standard specifies type tests, animal studies and clinical evaluation requirements.
Published
• (none) / (none) / (none)
PDF
30/03/2019
58
NSC 18 - Medical Devices and Facilities for Healthcare
