AS ISO 14708.1-2003

1 - AS ISO 14708.1-2003 IMPLANTS FOR SURGERY-ACTIVE IMPLANTABLE MEDICAL DEVICES - GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FO
4 - PREFACE
6 - CONTENTS
8 - INTRODUCTION
9 - 1 Scope
9 - 2 Normative references
10 - 3 Terms and definitions
10 - 3.1 medical device
10 - 3.2 active medical device
10 - 3.3 active implantable medical device
11 - 3.4 catheter
11 - 3.5 lead
11 - 3.6 non-reusable pack
11 - 3.7 sterile pack
11 - 3.8 sales packaging
11 - 3.9 marking
11 - 3.10 label
11 - 3.11 radioactive substance
11 - 3.12 sealed source
11 - 3.13 medicinal substance
11 - 3.14 harm
12 - 3.15 hazard
12 - 3.16 unacceptable hazard
12 - 3.17 hazard control
12 - 3.18 portable equipment
12 - 3.19 hand-held equipment
12 - 4 Symbols and abbreviated terms
12 - 5 General requirements for non-implantable parts
12 - 6 Requirements for particular active implantable medical devices
13 - 7 General arrangement of the packaging
13 - 8 General markings for active implantable medical devices
13 - 9 Markings on the sales packaging
14 - 10 Construction of the sales packaging
15 - 11 Markings on the sterile pack
16 - 12 Construction of the non-reusable pack
16 - 13 Markings on the active implantable medical device
17 - 14 Protection from unintentional biological effects caused by the active implantable medical device
18 - 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device
18 - 16 Protection from harm to the patient caused by electricity
18 - 17 Protection from harm to the patient caused by heat
18 - 18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 - 19 Protection from unintended effects caused by the device
20 - 20 Protection of the device from damage caused by external defibrillators
22 - 21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient
22 - 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
22 - 23 Protection of the active implantable medical device from mechanical forces
23 - 24 Protection of the active implantable medical device from damage caused by electrostatic discharge
24 - 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes
24 - 26 Protection of the active implantable medical device from damage caused by temperature changes
25 - 27 Protection of the active implantable medical device from electromagnetic non- ionizing radiation
25 - 28 Accompanying documentation
28 - Annex A - Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this part of...
40 - Annex B - Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in...
42 - Annex C - Rationale
42 - C.1 Introduction
42 - C.2 General
42 - C.3 Notes on specific clauses and subclauses
48 - Bibliography

Specifies requirements that are generally applicable to active implantable medical devices. For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of ISO 14708. Special care is required in applying ISO 14708-1 to active implantable medical devices where no particular standard exists. The tests that are specified in ISO 14708-1 are type tests intended to be carried out on samples of a device to show compliance, and are not intended to be used for the routine testing of manufactured products. Applicable to active implantable medical devices that are electrically powered, devices powered by other energy sources (for example gas pressure or springs) and to some non-implantable parts and accessories of the devices.

This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.NOTE For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of ISO 14708. Special care is required in applying this part of ISO 14708 to active implantable medical devices where no particular standard exists.The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on samples of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.This part of ISO 14708 is applicable not only to active implantable medical devices that are electrically powered, but also to those powered by other energy sources (for example gas pressure or springs).This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (see 3.3).

First published as AS ISO 14708.1-2003.