AAMI 8638 2010 RA 2015
$93.55
ANSI/AAMI/ ISO 8638:2010/(R)2015 – Cardiovascular implants and extracorporeal systems-Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 26 |
Specifies requirements for the single-use extracorporeal blood circuit and (integral and nonintegral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration and hemofiltration.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 8638:2010/(R)2015, Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| 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 |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 8638:2010 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 Requirements 4.1 Biological safety 4.2 Sterility 4.3 Nonpyrogenicity 4.4 Mechanical characteristics 4.4.1 Structural integrity 4.4.2 Connectors to hemodialyzer, hemodiafilter or hemofilter 4.4.3 Connectors to vascular access device 4.4.4 Connectors to ancillary components |
| 16 | 4.4.5 Color coding 4.4.6 Access ports 4.4.6.1 Needle access ports 4.4.6.2 Needleless access ports |
| 17 | 4.4.7 Blood pathway volume 4.4.8 Air-capture chamber fill level 4.4.9 Transducer protectors 4.4.9.1 Integral transducer protectors 4.4.9.2 Non-integral transducer protectors 4.4.10 Blood pathway flow dynamics 4.4.11 Pump segment performance 4.5 Expiry date |
| 18 | 4.6 Tubing compliance 5 Test methods 5.1 General 5.2 Biological safety 5.3 Sterility 5.4 Nonpyrogenicity |
| 19 | 5.5 Mechanical characteristics 5.5.1 Structural integrity 5.5.1.1 Positive pressure 5.5.1.2 Negative pressure 5.5.2 Connectors to hemodialyzer, hemodiafilter or hemofilter 5.5.3 Connector to vascular access device 5.5.4 Connectors to ancillary components 5.5.5 Color coding |
| 20 | 5.5.6 Access ports 5.5.6.1 Needle access ports |
| 21 | 5.5.6.2 Needleless access ports 5.5.7 Blood pathway volume 5.5.8 Air-capture chamber fill level 5.5.9 Transducer protectors 5.5.10 Blood pathway flow dynamics |
| 22 | 5.5.11 Pump segment performance |
| 23 | 5.6 Expiry date 5.7 Tubing compliance 6 Labeling 6.1 Labeling on the device 6.2 Labeling on the unit container |
| 24 | 6.3 Labeling on the outer container 6.4 Accompanying documentation |
| 26 | Bibliography |
