AAMI 18241 2016
$93.55
ANSI/AAMI/ISO 18241:2016 – Cardiovascular implants and extracorporeal systems-Cardiopulmonary bypass systems-Venous bubble traps
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 22 |
Specifies requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 18241:2016; Cardiovascular implants and extracorporeal systems—Cardiopulmonary bypass systems—Venous bubble traps |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of AAMI adoption of ISO 18241:2016 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity 4.1.2 Biocompatibility 4.2 Physical characteristics 4.2.1 Blood pathway integrity 4.2.2 Prime volume 4.2.3 Connectors 4.3 Performance characteristics 4.3.1 Blood cell damage |
| 16 | 4.3.2 Air removal efficiency 4.3.3 Flow rate capacity 4.3.4 Shelf life 5 Tests and measurements to determine compliance with this document 5.1 General 5.2 Biological characteristics 5.2.1 Sterility and non-pyrogenicity 5.2.2 Biocompatibility 5.3 Physical characteristics 5.3.1 Blood pathway integrity |
| 17 | 5.3.2 Prime volume 5.3.3 Connectors 5.4 Performance characteristics 5.4.1 Blood cell damage 5.4.1.1.1 Test liquid 5.4.1.1.2 Procedure Table 1 — Conditions for in vitro testing of blood cell damage |
| 18 | Table 2 — Sampling schedule 5.4.2 Air removal efficiency 5.4.2.1.1 Test liquid 5.4.2.1.2 Procedure 5.4.2.1.3 Results |
| 19 | 5.4.3 Flow rate and pressure drop 5.4.3.1.1 Test liquid 5.4.3.1.2 Procedure 5.4.4 Shelf life 6 Information supplied by the manufacturer 6.1 Information on the venous bubble trap 6.2 Information on the packaging 6.2.1 Information on the unit container |
| 20 | 6.2.2 Information on the shipping container 6.3 Information in the accompanying documents |
| 21 | 6.4 Information in the accompanying documents in a prominent form 7 Packaging |
| 22 | Bibliography |
