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SN EN 45502-1 : 1997
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The latest, up-to-date edition.
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ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 (Vacant)
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
Annexes
A (informative) Relationship between the clauses of
this standard and annex 1 of Directive 90/385/EEC
B (informative) Relationship between the clauses of this
standard and the essential requirements (90/385/EEC)
listed in annex A
C (informative) Notes on EN 45502-1
D (informative) Bibliography
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