ISO INTERNATIONAL STANDARD 11608-5 Second edition 2022-04 Needle-based injection systems for medical use Requirements and test methods - Part 5: Automated functions Systemes d'injection a aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées Reference number IS0 11608-5:2022(E) ISO @ IS0 2022 IS0 11608-5:2022(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 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 orIso'smemberbodyinthecountryoftherequester. ISO copyright office CP401·Ch.deBlandonnet8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Publishedin Switzerland ii @ IS0 2022 - All rights reserved IS0 11608-5:2022(E) Contents Page iv Foreword Introduction .V Scope. 1 1 2 Normative references .1 3 Terms and definitions .2 4 Requirements. 4 4.1 General requirements 4 4.2 Medicinal product preparation 5 4.3 Needle preparation 6 4.4 Needle hiding. 6 Priming. 4.5 6 Dose setting 4.6 6 4.7 Needle insertion. 6 4.8 Injection depth control. 6 4.9 Dose delivery 7 4.10 Recording of device functions 7 4.11 Needle retraction. 7 4.11.1 Completion of dose delivery 7 4.11.2 Needle retraction distance. 7 4.11.3 Communication of completion 7 4.12 Disabling the NIS-AUTO 7 Needle shielding 4.13 8 4.13.1 General 8 4.13.21 Needle shielding before injection 8 Needle shielding after injection. 4.13.3 8 4.14 Needle removal from the NIS-AUTO 8 5 Test methods. .8 5.1 General. 8 5.2 Test conditions. 9 5.3 Actuation 9 5.4 Medicinal product preparation 9 5.5 Needle inspection 9 5.6 Needle hiding 9 5.7 Priming.... 10 5.8 Needle extension 10 5.9 Injection time. 10 5.10 Dose accuracy. 11 5.11 Retracted position. 11 5.12 Disabling the NIS-AUTO 11 Needle shielding. 5.13 11 5.13.1 Needle shielding before and after injection 11 5.13.2 Needle shielding after free fall. 11 .11 6 Information supplied with the NIS-AUTO .12 Annex A (informative) Rationale for requirements. Annex B (informative) Example of a test method for dose accuracy at intended injection depth .14 .16 Annex C (informative) Needle extension and intended injection depth Bibliography .22 @ IS0 2022 - All rights reserved iii