Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms (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 unintended 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 instruments
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
   changes caused by temperature changes
27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   electromagnetic non-ionizing radiation
28 Accompanying documentation
Annex A (informative) - Relationship between the fundamental
        principles in ISO/TR 14283 and the clauses of this
        standard
Annex B (informative) - Relationship between the clauses of
        this standard and the fundamental principles listed in
        Annex A
Annex C (informative) - Notes on ISO 14708-6
Annex D (informative) - Code for describing modes of IMPLANTABLE
        PULSE GENERATORS
Annex E (normative) - Interface circuits
Annex F (informative) - Selection of capacitor C[x]
Annex G (normative) - Calibration of injection network;
        Test signal of inhibition generator
Annex H (informative) - Defined terms
Bibliography

Abstract

Describes requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150