| Name | Support | Language | Availability | Edition date | Price | ||
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PDF |
English |
Active |
1/1/2012 |
€123.00 |
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Details
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. Rather than rewrite the existing standards, a single standard will address the composition, the mechanical and biological characteristics, performance and safety of these coating for all the components. Annex 3
Additional Info
| Author | Association for the Advancement of Medical Instrumentation (AAMI) |
|---|---|
| Published by | AAMI |
| Document type | Standard |
| Theme | Implants & Artificial Organs |
| Keyword | ANSI/AAMI/ISO 11658:2012 |
