AAMI 14708 4 2008 RA 2011
$131.66
ANSI/AAMI/ISO 14708-4:2008/(R)2011 – Implants for surgery-Active implantable medical devices-Part 4: Implantable infusion pumps
| Published By | Publication Date | Number of Pages |
| AAMI | 2008 | 58 |
Specifies requirements for the safety and performance of active implantable infusion pumps.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 14708-4:2008/(R)2011, Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO 14708-4:2008 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 Symbols and abbreviated terms 5 General requirements for non-implantable parts |
| 16 | 6 Requirements for particular active implantable medical devices 6.101 Implantable infusion pump characteristics 6.102 Septum puncture test |
| 17 | 7 General arrangement of the packaging 8 General markings for active implantable medical devices |
| 18 | 9 Markings on the sales packaging 10 Construction of the sales packaging 11 Markings on the sterile pack |
| 19 | 12 Construction of the non-reusable pack 13 Markings on the active implantable medical device 14 Protection from unintentional biological effects caused by the active implantable medical device |
| 20 | 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device |
| 21 | 16 Protection from harm to the patient caused by electricity 17 Protection from harm to the patient caused by heat 18 Protection from ionizing radiation released or emitted from the active implantable medical device 19 Protection from unintended effects caused by the device |
| 22 | 20 Protection of the device from damage caused by external defibrillators 21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments |
| 23 | 23 Protection of the active implantable medical device from mechanical forces 24 Protection of the active implantable medical device from damage caused by electrostatic discharge 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes 26 Protection of the active implantable medical device from damage caused by temperature changes |
| 24 | 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation 27.101 Immunity 27.102 General test conditions |
| 26 | 27.103 Protection from static magnetic fields |
| 27 | 27.104 Protection from magnetic fields in the range 10 Hz to 30 MHz |
| 29 | 27.105 Protection from electromagnetic fields in the range 30 MHz to 450 MHz |
| 30 | 27.106 Protection from electromagnetic fields in the range 450 MHz to 3 GHz |
| 31 | 28 Accompanying documentation |
| 33 | Annex AA Relationship between the fundamental principles in ISO/TR 14283 [8] and the clauses of this part of ISO 14708 |
| 45 | Annex BB Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA |
| 47 | Annex CC Rationale CC.1 General CC.2 Notes on specific clauses and subclauses |
| 57 | Bibliography |
