11/30243761 DC : 0
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The latest, up-to-date edition.
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English
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 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) - Relationship between
the fundamental principles in ISO/TR 14283
and the clauses of this standard
Annex BB (informative) - Relationship between
the clauses of this standard and the
fundamental principles listed in Annex A
Annex CC (informative) - Notes on EN 45502-2-3
Annex DD (informative) - Notes on theoretical modelling
to demonstrate compliance to Clause 27
Annex EE (informative) - Notes on EMI measurements to
demonstrate compliance to Clause 27
Bibliography
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