Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations (optional)
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 nonionizing radiation
28 Accompanying documentation
Annex A (informative) - General guidance and rationale
Annex B (informative) - Relationship between the fundamental
        principles in ISO/TR 14283:2004 and the clauses
        of this part of ISO 14708
Bibliography

Abstract

This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150
Supersedes	ISO/DIS 14708-1 : 60.00 (2014) ISO 14708-1 : 2000