ISO INTERNATIONAL STANDARD 14708-3 Secondedition 2017-04 Implants for surgery Active implantable medical devices Part 3: Implantable neurostimulators Implants chirurgicaux - Dispositifs médicaux implantables actifs Partie 3: Neurostimulateurs en implant Reference number IS0 14708-3:2017(E) International Organization for Standardization eeZHEJIANG INST OF STANDARDIZATION C1 5956617 @ IS0 2017 mitted without license from IHS IS0 14708-3:2017(E) COPYRIGHT PROTECTEDDOCUMENT IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Licensee-ZHEJIANG INST OF STANDARDIZAISQ 017 - All rights reserVed HS und networking permited without license from IHS IS0 14708-3:2017(E) Contents Page Foreword ..V Introduction ..vi 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions ..1 4 Symbols and abbreviated terms ..2 5 .2 General requirements for active implantable medical devices. 6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES ..2 7 3 General arrangement of the packaging 8 General markings for ACTIVE IMPLANTABLE MEDICAL DEVICES 9 Markings on the sales packaging. ..3 10 Construction of the sales packaging ..3 11 Markings on the sterile pack .3 12 Construction of the non-reusable pack. ..3 13 MarkingS on the ACTIVE IMPLANTABLE MEDICAL DEVICE ...3 14 Protection from unintentional biological effects being caused by the AcTivE IMPLANTABLEMEDICALDEVICE. ..3 15 Protection from harm to the patient or user caused by external physical features of theACTIVEIMPLANTABLEMEDICALDEVICE. .3 16 Protection from harm to the patient caused by electricity .3 17 Protection from harm to the patient caused by heat ..3 18 Protection from ionizing radiation released or emitted from the active implantable medical device. 4 19 Protection from unintended effects caused by the AcTIVE IMPLANTABLE MEDICAL DEVICE ....4 20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external defibrillators 5 21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes cauSed by electrical fields applied directly to the patient .5 22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by miscellaneousmedicaltreatments. 5 23 Protection of the AcTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces ..6 24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic discharge. .6 25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmosphericpressurechanges. .7 26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature changes. .7 27 Protection of the active implantable medical device from electromagnetic non- ionizingradiation .7 28 Accompanying documentation .16 iii thout license from IHS Not for Resale, 2017/6/28 00:59:53