ISO INTERNATIONAL STANDARD 14708-6 Second edition 2019-09 Implants for surgery - Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) Implants chirurgicauxDispositifs medicaux implantables actifs Partie6:Exigences particulieres pourles dispositifsmedicaux lesdefibrillateursimplantables) Referencenumber IS014708-6:2019(E) ISO @IS02019 IS014708-6:2019(E) COPYRIGHTPROTECTEDDOCUMENT IS02019 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may on the internet or an intranet, without prior written permission. Permission can be requested from either Iso at the address beloworIso'smemberbodyinthecountryoftherequester. ISO copyright office CP401:Ch.de Blandonnet8 CH-1214 Vernier,Geneva Phone:+41227490111 Fax:+41227490947 Email:[email protected] Website: www.iso.org Published in Switzerland ii IS0 2019-All rights reserved IS014708-6:2019(E) Contents Page Foreword V Introduction ..vi 1 Scope. 2 Normativereferences .1 3 Terms and definitions .2 4 Symbols andabbreviated terms. .6 5 Generalrequirementsfornon-implantableparts .6 5.1 Generalrequirementsfornon-implantableparts .6 5.2 Generalrequirementsforsoftware. 6 5.3 Usabilityof non-implantableparts 6 5.4 Data security and protection fromharm causedby unauthorized informationtampering 6 5.5 General requirementsforriskmanagement 6 5.6 Misconnectionofparts oftheactive implantablemedical device .6 Measurementof implantablepulsegeneratorandlead characteristics .6 6 6.1 Measurementof implantablepulsegeneratorcharacteristics. 6 6.1.1 General considerations.. .6 6.1.2 Measurementofthebradyarrhythmiacharacteristics .7 6.1.3 MeasurementofIcDoutputvoltage 6.1.4 MeasurementofdeliveredcDpulseenergy. .8 6.1.5 Measurementoftheantitachyarrhythmiapacingpulseamplitude 8 6.1.6 Measurementofthesensitivityofanimplantablepulsegeneratorwith automatic sensitivity control. .8 6.1.7 Chargetime.. .9 6.1.8 Capacitorformation (capacitormaintenance) 9 6.2 Measurement of theelectrical characteristicofa sensing/pacing lead .9 7 General arrangementofthepackaging .9 8 General markings for active implantable medical devices 9 9 Markings onthesalespackaging .9 10 Constructionofthe sales packaging. .11 11 Markings on the sterile pack. .11 12 Construction ofthe non-reusablepack ..13 13 Markings ontheactiveimplantablemedical device ..13 14 Protectionfromunintendedbiologicaleffectsbeingcausedbytheactive implantablemedical device. .13 15 Protectionfrom harmtothepatientor user caused by external physical features of theactiveimplantablemedical device .14 16 Protectionfromharmtothepatientcaused byelectricity .14 17 Protectionfromharmtothepatientcausedbyheat. .18 17.1Protectionfromharmtothepatientcausedbyheat .18 17.2Activeimplantablemedicaldeviceintendedtosupplyheat .19 18 Protectionfrom ionizingradiationreleased oremitted fromthe active implantable medical device.. .19 19 Protectionfromunintended effectscausedbythedevice .19 20 Protectionof thedevicefromdamage causedbyexternal defibrillators .20 IS0 2019 -All rights reserved iii