SN EN 45502-1 : 1997

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

Defines requirements which apply generally to active implantable medical devices, for provision of basic assurance of safety for patients and users.