ISO INTERNATIONAL STANDARD 14708-4 Second edition 2022-02 Implants for surgery Active implantable medical devices - Part 4: Implantable infusion pump systems Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 4: Systemes de pompe a perfusion implantables Reference number IS0 14708-4:2022(E) ISO @IS02022 IS0 14708-4:2022(E) COPYRIGHT PROTECTED DOCUMENT IS02022 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may the internet or an intranet, withoutpriorwrittenpermission.Permission can be requested from eitherIso at the addressbelow or Iso's member body in the country of the requester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214Vernier,Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org PublishedinSwitzerland i @ IS0 2022 - All rights reserved IS0 14708-4:2022(E) Contents Page Foreword V Introduction ..vii 1 Scope. .1 2 Normative references. .1 3 Terms and definitions .1 4 Symbols and abbreviated terms. .3 5 General requirements for active implantable medical devices .3 5.1 General requirements for non-implantable parts. .3 5.2 Generalrequirementsforsoftware... .3 5.3 Usability of non-implantable parts. .3 5.4 Data security and protection from harm caused by unauthorized information tampering. .3 5.5 Generalreguirementsforriskmanagement .3 5.6 Misconnection of parts of the active implantable medical device .3 6 Requirements for particular active implantable medical devices 6.1 Implantable infusion pump system specifications .3 6.2 Septum puncture test. 4 7 General arrangement of the packaging ..5 8 General markings for active implantable medical devices. .5 9 Markings on the sales packaging .6 10 Construction of the sales packaging .6 11 Markings on the sterile pack .7 12 Construction of the non-reusable pack 7 13 Markings on the active implantable medical device. 7 14 Protection from unintentional biological effects caused by the active implantable medicaldevice 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device.. 8 16 Protection from harm to the patient caused by electricity 8 17 Protection from harm to the patient caused by heat 8 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. 10 21 Protection of the active implantable medical device from changes caused by high- power electrical fields applied directly to the patient. 10 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments 10 22.1 Diagnostic ultrasound. 10 22.2 Magnetic resonance imaging. ..10 23 Protection of the active implantable medical device from mechanical forces .11 24 Protection of the active implantable medical device from damage caused by electrostatic discharge. 12 @ IS0 2022 - All rights reserved iii IS0 14708-4:2022(E) 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes. 12 26 Protection of the active implantable medical device from damage caused by temperature changes 12 27 Protection of the active implantable medical device from electromagnetic non- ionizingradiation .12 27.1 General ..12 27.2 Test conditions. .13 27.2.1 Acceptance criteria. .13 27.2.2 Test configuration. .13 27.2.3 Operating functions, modes, and settings. .13 27.3 Documentation. .13 27.4 Protection from static magnetic fields of flux density up to 50 mT .14 27.5 Protection from magnetic fields over the frequency range 16 Hz to 26 MHz .15 27.6 Protection from EM disturbances over the frequency range 80 MHz to 2,7 GHz 16 27.7 Protection from proximity fields due to RF wireless communications equipment .17 27.8 Optional characteriz