Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for non-implantable parts
6 Measurements of implantable pulse generator
   and lead characteristics
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 pack
12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects
   being 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 14283 and the clauses
         of this International Standard
Annex BB (informative) - Relationship between the clauses
         of this part of ISO 14708 and the fundamental
         principles in Annex A
Annex CC (informative) - Rationale
Annex DD (informative) - Code for describing modes of
         implantable pulse generators
Annex EE (informative) - Symbols
Annex FF (normative) - Pulse forms
Bibliography

Abstract

Describes requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO 14708-2 : 2005 CSA ISO 5841-1 : 0