AAMI 15676 2016
$75.64
ANSI/AAMI/ISO 15676:2016 – Cardiovascular implants and artificial organs-Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 19 |
Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 15676:2016; Cardiovascular implants and artificial organs—Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents Page |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Background of AAMI adoption of ISO 15676:2016 |
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions |
| 13 | 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity 4.1.2 Biocompatibility 4.2 Physical characteristics 4.2.1 General 4.2.2 Dimensions 4.2.3 Material properties |
| 14 | 4.3 Performance characteristics 4.3.1 Priming volume 4.3.2 Life to failure testing 4.3.3 Spallation 4.3.4 Shelf life 5 Tests and measurements 5.1 General 5.2 Biological characteristics 5.2.1 Sterility and non-pyrogenicity |
| 15 | 5.2.2 Biocompatibility 5.3 Physical characteristics 5.3.1 Blood pathway integrity 5.3.2 Connections 5.3.3 Tubing material property testing 5.4 Performance characteristics 5.4.1 Tubing life 5.4.2 Spallation in tubing used in roller pumps |
| 16 | 5.4.3 Shelf life 6 Information supplied by the manufacturer 6.1 Information on the tubing pack 6.1.1 Information on the unit container 6.1.2 Information on the shipping container |
| 17 | 6.2 Information on the accompanying documents 6.3 Information in the accompanying documents in a prominent form 6.4 Information to be provided by manufacturer upon request |
| 18 | 7 Packaging |
| 19 | Bibliography |
