AAMI 15675 2016
$65.83
ANSI/AAMI/ISO 15675:2016 – Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial blood line filters
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 20 |
Specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 15675:2016; Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—arterial blood line filters |
| 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 15675:2016 |
| 9 | Foreword |
| 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 Blood pathway integrity 4.2.2 Blood volume 4.2.3 Connectors 4.3 Performance characteristics 4.3.1 Blood cell damage |
| 14 | 4.3.2 Filtration efficiency 4.3.3 Flow rate capacity 4.3.4 Shelf life 4.3.5 Air-handling capability 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 |
| 15 | 5.3 Physical characteristics 5.3.1 Blood pathway integrity (sterile final assembly) 5.3.2 Blood volume 5.3.3 Connectors 5.4 Performance characteristics 5.4.1 Blood cell damage 5.4.1.1 Test media 5.4.1.2 Procedure Table 1 — Conditions for in vitro testing of blood cell damage |
| 16 | Table 2 — Sampling schedule 5.4.2 Filtration efficiency 5.4.2.1 Test liquid 5.4.2.2 Procedure 5.4.3 Filter flow rate 5.4.3.1 Test liquid 5.4.3.2 Procedure 5.4.4 Shelf life |
| 17 | 5.4.5 Air-handling capability 5.4.5.1 Test liquid 5.4.5.2 Procedure 5.4.5.3 Test results 6 Information supplied by the manufacturer 6.1 Information on the arterial blood line filter 6.2 Information on the packaging 6.2.1 Information on the unit container |
| 18 | 6.2.2 Information on the shipping container 6.3 Information in the accompanying documents |
| 19 | 6.4 Information in the accompanying documents in a prominent form 7 Packaging |
| 20 | Bibliography |
