Glossary of equivalent standards
Background of AAMI adoption of ISO
14708-3:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for active
implantable medical devices
6 Requirements for particular active
implantable medical devices
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 ACTIVE IMPLANTABLE MEDICAL DEVICE
20 Protection of the ACTIVE IMPLANTABLE MEDICAL
DEVICE from damage caused by external
defibrillators
21 Protection of the ACTIVE IMPLANTABLE
MEDICAL DEVICE from changes caused by
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 (normative) - Relationship between
the fundamental principles in
ISO/TR 14283 [1] and the clause
of this document
Annex BB (informative) - Rationale
Annex CC (informative) - Injection network
example and board layout guidance
Bibliography