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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.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2015-11-20 |
ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
Cross references | ISO 14708-5 (2010-02), IDT |
Year | 2010 |
Document history | |
Country | USA |
Keyword | ANSI 14708;ANSI/AAMI/ISO 14708;14708;ANSI/AAMI/ISO 14708-5-2010 (R2015) |