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