AAMI 18242 2016
$75.64
ANSI/AAMI/ISO 18242:2016 – Cardiovascular implants and extracorporeal systems-Centrifugal blood pumps
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 20 |
Specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 18242:2016; Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps |
| 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 18242:2016 |
| 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 Blood pathway integrity 4.2.2 Prime volume 4.2.3 Connector integrity 4.3 Performance characteristics 4.3.1 Hydraulic performance 4.3.2 Blood cell damage |
| 14 | 4.3.2.1 Plasma-free hemoglobin 4.3.2.2 Platelet reduction 4.3.2.3 White blood cell reduction 4.3.3 Bearing durability 4.3.4 Shelf life 5 Tests and measurements to determine compliance with this document 5.1 General 5.1.1 Tests and measurements 5.1.2 Operating variables 5.1.3 Temperature 5.1.4 Relationship between variables 5.1.5 Procedures |
| 15 | 5.1.6 Driver/console 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 Prime volume 5.3.2.1 Test liquid 5.3.2.2 Procedure 5.3.3 Connectors 5.3.3.1 Procedure |
| 16 | 5.4 Performance characteristics 5.4.1 Hydraulic performance 5.4.1.1 Test liquid 5.4.1.2 Procedure 5.4.2 Blood cell damage 5.4.2.1 Test liquid 5.4.2.2 Procedure Table 1 — Conditions for in vitro testing of blood cell damage |
| 17 | Table 2 — Sampling schedule 5.4.3 Bearing wear 5.4.3.1 Test liquid 5.4.3.2 Procedure 5.4.4 Shelf life 6 Information supplied by the manufacturer 6.1 Information on the device |
| 18 | 6.2 Information on the packaging 6.2.1 Unit container 6.2.2 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 |
