ISO INTERNATIONAL STANDARD 14708-7 Second edition 2019-12 Implants forsurgery-Active implantablemedicaldevices- Part 7: Particular requirements for cochlear andauditorybrainstemimplant systems ImplantschirurgicauxDispositifsmedicauximplantablesactifs- Partie 7: Exigences particulieres pour les systemes d'implant cochleaireetd'implantauditif dutronccérebral Referencenumber IS014708-7:2019(E) ISO @IS02019 IS014708-7:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2019 All rights reserved. Unless otherwise specified,or required in the context of its implementation, no part of this publication may bereproduced orutilized otherwise in anyform or byany means,electronic ormechanical, includingphotocopying,orposting 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-1214Vernier, Geneva Phone:+41227490111 Fax: +41 22 749 09 47 Email:[email protected] Website: www.iso.org Published in Switzerland ii IS02019-Allrightsreserved IS014708-7:2019(E) Contents Page Foreword .V Introduction. .vi 1 Scope.. .1 2 Normativereferences .1 3 Terms and definitions .2 4 Symbols andabbreviations .3 5 Generalrequirementsfornon-implantableparts .3 5.1 Generalrequirementsfornon-implantableparts 3 5.2 Generalreguirementsforsoftware. 3 5.3 Usabilityofnon-implantableparts. 3 5.4 Data securityandprotection fromharm caused byunauthorized information tampering3 5.5 Generalrequirementsforriskmanagement 5.6 Misconnectionofparts of the active implantablemedicaldevice .3 5.7 Protectionagainstexternal electricalhazardsforfully implantablesystems. .3 6 Inspectionandmeasurement 4 6.1 General 4 6.2 Measurementofoutputsignal characteristics 4 6.3 Measurementoftheoutputsignal amplitudeandpulsewidth .4 6.4 Impedancemeasurementaccuracy 4 6.5 Inductivelink characterization 4 6.6 Soundprocessorbatterytesting. 7 Generalarrangementofthepackaging .4 8 Generalmarkingsforactiveimplantablemedicaldevices .4 9 Markings on the sales packaging .4 10 Construction ofthe sales packaging .5 11 Markings onthesterilepack .5 12 Constructionofthenon-reusablepack .5 13 Markings ontheactive implantablemedicaldevice .5 14 Protection fromunintentional biologicaleffects being causedbytheactive implantablemedicaldevice 6 15 Protectionfrom harmtothepatientor usercaused by external physicalfeaturesof theactiveimplantablemedicaldevice 6 16 Protectionfrom harmtothepatientcaused byelectricity 6 17 .7 Protectionfromharmtothepatientcausedbyheat 18 Protectionfromionizingradiationreleasedoremittedfromtheactiveimplantable medicaldevice. .8 19 Protectionfromunintendedeffectscausedbythedevice .8 20 Protectionofthedevicefromdamagecausedbyexternaldefibrillators .9 21 Protectionofthedevicefromchangescausedbyhighpowerelectricalfields .9 applieddirectlytothepatient. 22 Protectionoftheactiveimplantablemedical devicefromchangescausedby .10 miscellaneousmedicaltreatments 23 Protectionoftheactiveimplantablemedicaldevicefrommechanicalforces .18 IS0 2019-All rights reserved ili