AAMI 11658 2012
$65.83
ANSI/AAMI/ISO 11658:2012 – Cardiovascular implants and extracorporeal systems – Blood/tissue contact surface modifications for extracorporeal perfusion systems
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 20 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11658:2012, Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modification for extracorporeal perfusion systems |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of AAMI adoption of ISO 11658:2012 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity |
| 15 | 4.1.2 Biocompatibility 4.1.3 Biological activity 4.2 Physical characteristics 4.2.1 Blood pathway integrity 4.2.2 Blood pathway coverage 4.2.3 Surface modification integrity 4.3 Performance characteristics 4.3.1 Blood cell damage 4.3.2 General performance 4.3.3 Shelf life 5 Tests 5.1 General |
| 16 | 5.2 Biological characteristics 5.2.1 Sterility and non-pyrogenicity 5.2.2 Biocompatibility 5.2.3 Biological activity 5.3 Physical characteristics 5.3.1 Determination of blood pathway integrity (sterile final assembly) |
| 17 | 5.3.2 Determination of surface modification coverage 5.3.3 Determination of surface modification integrity 5.4 Performance characteristics 5.4.1 Blood cell damage 5.4.2 General performance 5.4.3 Shelf life |
| 18 | 6 Information supplied by the manufacturer 6.1 General 6.2 Information to be given in the accompanying documents |
| 19 | Bibliography |
