Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations
5 General requirements for non-implantable parts
6 Inspection and measurement
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 nonionising radiation
28 Accompanying documentation
Annex AA (informative) - Relationship between the fundamental
         principles in ISO/TR 14283 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 A
Annex CC (informative) - Notes on EN 45502-2-3 (basis for
         this part of ISO 14708)
Annex DD (informative) - Notes on theoretical modelling to
         demonstrate compliance with Clause 27
Annex EE (informative) - Notes on EMI measurements to
         demonstrate compliance with Clause 27
Bibliography

Abstract

Describes requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150