AAMI/ISO 14708-5 specifies requirements for safety and performance of active implantable circulatory support devices. Excluded from this scope are intra-aortic balloon pumps, external corporeal perfusion devices and cardiomyplasty. This standard specifies type tests, animal studies and clinical evaluation requirements that are to be carried out to show compliance with this standard.
- Published:
- 04/01/2010
- ISBN(s):
- 1570203784
- ANSI:
- ANSI Approved
- Number of Pages:
- 62
- File Size:
- 1 file , 470 KB
- Same As:
- AAMI/ISO 14708-5:2010/(R)2015
- Note:
- This product is unavailable in Ukraine, Russia, Belarus
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