CEI UNI EN 45502-2-3 : 2010

Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
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 non-ionising radiation
28 Accompanying documentation
Annex AA (informative) - Notes on EN 45502-2-3
Annex BB (informative) - Notes on theoretical modelling
         to demonstrate compliance to Clause 27
Annex CC (informative) - Notes on EMI measurements
         to demonstrate compliance to Clause 27
Bibliography

Describes the requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways.