AAMI ISO 14708-5 : 2010

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for non-implantable parts
6 Requirements for particular active implantable medical
   devices
7 General arrangement of the packaging
8 General markings for active implantable medical devices
9 Markings on the sales packaging
10 Construction of the sales packaging
11 Markings on the sterile packaging
12 Construction of the non-reusable packaging
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects caused by
   the active implantable medical device
15 Protection from harm to the patient or user caused by
   external physical features of the active implantable
   medical device
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
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 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
27 Protection of the active implantable medical device from
   electromagnetic non-ionizing radiation
28 Accompanying documentation
Annex AA (informative) - Relationship between the fundamental
                         principles in ISO/TR and the clauses
                         of this part of ISO 14708
Annex BB (informative) - Relationship between the clauses of
                         this part of ISO 14708 and the
                         fundamental principles listed in
                         Annex AA
Annex CC (informative) - Rationale
Annex DD (informative) - In vitro test
Bibliography

Describes requirements for safety and performance of active implantable circulatory support devices.