ISO INTERNATIONAL STANDARD 11608-6 First edition 2022-04 Needle-based injection systems for medical use Requirements and test methods - Part 6: On-body delivery systems Systemes d'injection d aiguille pour usage medical-Exigences et méthodes d'essai- Partie6:Systemesd'administration sur le corps Reference number IS0 11608-6:2022(E) ISO @ISO2022 IS011608-6:2022(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2022 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 CP401·Ch.deBlandonnet8 CH-1214 Vernier,Geneva Phone: +41 22 749 01 11 Email:[email protected] Website: www.iso.org Published in Switzerland ii @IS0 2022-All rights reserved IS011608-6:2022(E) Contents Page Foreword iv Introduction .V 1 Scope. .1 2 Normativereferences .1 3 Termsand definitions. .1 4 Requirements. .3 4.1 General. 3 4.2 Risk assessment. 3 4.3 Usability engineering. 3 4.4 Uncertainty of measurement and conformance with specifications. 3 4.5 General design requirements 3 3 4.6 Physical ormechanicalrequirementsandtestmethods 4.6.1 General 3 4.6.2 Systems comprising rigid needles 3 4.6.3 Systems comprising a soft cannula(s) 3 4.6.4 Leakage from the OBDS. 3 4.6.5 Means of attachment. 4 4.6.6 Occlusion 4 4.7 Functional performancerequirements andtest methods 5 4.7.1 General 5 4.7.2 Dosingrequirements and methods 5 4.7.3 Sharps injury protection 6 4.7.4 Automated functions. 6 4.7.5 Injection depthand needle extension 7 4.8 Biological requirements oftheOBDS 7 4.8.1 Sterility of OBDS 7 4.8.2 Biocompatibility 7 4.9 Medicinal product compatibility 7 4.9.1 General 7 4.9.2 Particulates 7 4.9.3 Pyrogenicity 7 4.9.4 Extractable/leachables 7 4.10 Electricalsafetyandsoftwarerequirements 8 4.10.1 Electrical safety 8 4.10.2 Software.. 8 5 Inspection. .8 6 Informationsuppliedbythemanufacturer .8 AnnexA(informative)Testmethodsforadhesion. .9 AnnexB (informative) Dose delivery profiles ..10 Annex C (informative) In vitromethods inrelationto needle/cannuladisplacement ..16 Bibliography .17 iii IS02022-Allrightsreserved