I.S. EN 45502-2-3:2010
Current
The latest, up-to-date edition.
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
Hardcopy , PDF
English
01-01-2010
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
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