AAMI 7199 2016
$75.64
ANSI/AAMI/ISO 7199:2016 – Cardiovascular implants and artificial organs-Blood-gas exchangers (oxygenators)
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 24 |
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 7199:2016; Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) |
| 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 |
| 7 | Committee representation |
| 8 | Background of AAMI adoption of ISO 7199:2016 |
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions |
| 14 | 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 Heat exchanger fluid pathway integrity 4.2.3 Blood volumes 4.2.4 Connectors 4.3 Performance characteristics 4.3.1 Oxygen and carbon dioxide transfer rates 4.3.2 Heat exchanger performance factor |
| 15 | 4.3.3 Integral arterial filtration efficiency 4.3.4 Integral arterial filter flow rate capacity 4.3.5 Integral arterial filter air handling capability 4.3.6 Blood cell damage 4.3.6.1 Plasma-free haemoglobin 4.3.6.2 Platelet reduction and white blood cell reduction 4.3.7 Time-dependent performance changes 4.3.8 Shelf life 5 Tests and measurements to determine compliance with this document 5.1 General |
| 16 | 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 5.3.1.1 Test liquid 5.3.1.2 Procedure 5.3.2 Heat exchanger water pathway integrity 5.3.2.1 Test liquid 5.3.2.2 Procedure 5.3.3 Blood volumes 5.3.3.1 Test liquid 5.3.3.2 Procedure 5.3.3.3 Residual blood volume |
| 17 | 5.3.4 Connectors 5.4 Performance characteristics 5.4.1 Oxygen and carbon dioxide transfer rates 5.4.1.1 Test media 5.4.1.2 Procedure 5.4.1.2.1 General 5.4.1.2.2 Clinical conditions |
| 18 | 5.4.2 Heat exchanger performance factor 5.4.2.1 Test liquid 5.4.2.2 Procedure 5.4.2.3 Equation 5.4.3 Blood cell damage 5.4.3.1 Test media 5.4.3.2 Procedure |
| 19 | 5.4.4 Shelf life 5.4.5 Filtration efficiency 5.4.5.1 Test liquid 5.4.5.2 Procedure 5.4.6 Integral arterial filter flow rate 5.4.6.1 Test liquid 5.4.6.2 Procedure 5.4.7 Air-handling capability of integral arterial filter 5.4.7.1 Test liquid 5.4.7.2 Procedure 5.4.7.3 Results |
| 20 | Table 1 — Conditions for in vitro testing of blood cell damage Table 2 — Sampling schedule 6 Information supplied by the manufacturer 6.1 Information on the oxygenator |
| 21 | 6.2 Information on the packaging 6.2.1 Unit container 6.2.2 Shipping container 6.3 Information in the accompanying documents |
| 23 | 6.4 Information in the accompanying documents in a prominent form 7 Packaging |
| 24 | Bibliography |
