ISO INTERNATIONAL STANDARD 18250-7 First edition 2018-12 Medical devices Connectors for reservoir delivery systems for healthcare applications - Part 7: Connectors for intravascular infusion Dispositifs medicaux-Connecteurs pour systemes de livraison de réservoirpourdesapplicationsdesoinsdesanté- Partie 7: Connecteurs pour perfusion intravasculaire Reference number IS0 18250-7:2018(E) Tso @ IS0 2018 IS0 18250-7:2018(E) COPYRIGHTPROTECTEDDOCUMENT IS02018 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 below or ISo's member body in the country of the requester. ISO copyright office CP 401: Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS0 18250-7:2018(E) Contents Page Foreword .iv Introduction .vi 1 *Scope .1 2 Normative references 3 Terms and definitions .2 4 General requirements .2 .2 4.1 Non-interconnectability through conformance to this document 4.2 *IntravascularRESERVOIRCoNNECTORtypes 2 5 Material requirements .3 5.1 CoNNEcTOR Type 1: spikes and administration ports .3 5.2 CoNNECTOR Type 2: LUERS 3 6 Dimensional requirements .3 CoNNEcToR Type 1: Spikes and Administration Ports 3 6.1 6.2 CoNNECTOR Type 2: LUERS Performance requirements .3 7.1 *CoNNEcToRType1:Spikes and Administration Ports 3 7.2 CoNNECTOR Type 2: LUERS 3 Annex A (informative)Rationaleand guidance 4 ..13 Annex B (normative) Design of coNNEcToRs* Annex C (informative) AssesSment of RESERvOIR CONNECTORS and their attributes with CONNECTIONStomedicaldeviceswithinthis intravascularAPPLICATION .15 Annex D (informative) Summary of usability and requirements for coNNEcToRs for intravaScularRESERVOIRS. .16 AnnexE (informative)Summary ofRESERvoIR coNNEcToRdesign requirementsfor INTRAVASCULAR INFUSION 19 AnnexF (informative) Summaryof engineeringanalysis and residual MiscoNNEcTioNsfor .24 CONNECTORSforintraVaScularRESERvOIRS Annex G (informative)Alternative spikes .30 .34 Bibliography @IS0 2018- All rights reserved iii