Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 Measurement of implantable pulse generator and lead
characteristics
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
Annex AA (informative) Table of cross-references from 90/385/EEC
to EN 45502-2-1
Annex BB (informative) Relationship between the clauses of
EN 45502 2-1 and the essential requirements of 90/385/EEC
listed in Annex AA
Annex CC (informative) Notes on EN 45502-2-1
Annex DD (informative) Code for describing modes of implantable
pulse generators
Annex EE (informative) Symbols
Annex FF (normative) Pulse forms
Annex GG (normative) Interface circuits
Annex HH (informative) Selection of capacitor C[x]
Annex II (normative) Calibration of the injection network, Figure GG.104
Figures
Tables