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AAMI/ISO 11658:2012
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systemsMore info
This standard will apply to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have a coating on the blood contact surface of the device. While standards exist for the main components used in heart-lung bypass and extracorporeal life support equipment, many of these components are currently distributed with a surface coating that comes in contact with blood. This aspect of the design of these components was not addressed in the existing standard.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2012-08-20 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Cross references | ISO 11658 (2012-05), IDT |
| Year | 2012 |
| Document history | |
| Country | USA |
| Keyword | ANSI 11658;11658;ANSI/AAMI/ISO 11658-2012 |