ISO INTERNATIONAL STANDARD 10555-6 Firstedition 2015-04-15 Intravascular catheters Sterile and single-use catheters - Part 6: Subcutaneous implanted ports Cathéters intravasculaires - Catheters stériles et non réutilisables - Partie 6: Chambres a cathéter implantables Reference number IS0 10555-6:2015(E) SO International Organization for Standardization @ IS0 2015 andardization5956617 IS0 10555-6:2015(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2015 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form 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 copyrightoffice Case postale 56:CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax +4122 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland PrganizationforStandardization by IHS und Not for Resale, 2015/6/29 08:52:29 networking permited without license from IHS IS0 10555-6:2015(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references .1 3 Terms and definitions 4 Requirements of the implantable subcutaneous implanted port and catheter .3 4.1 General .3 4.2 Biocompatibility .4 4.3 Distance markings. 4 4.4 Nominal dimensions of the subcutaneous implanted port .4 4.5 Physical requirements 4 4.5.1 Radio-detectability .4 4.5.2 Surface finish 4 4.5.3 Freedom from leakage 4 4.5.4 Flushing volume .4 4.5.5 Characteristics of the septum .5 4.5.6 Characteristics of the connection or the catheter. .5 4.6 Flowrate .5 4.6.1 Subcutaneous implanted ports not indicated for power injection ..5 4.6.2 Subcutaneous implanted ports indicated for power injection. .5 4.7 Burst pressure of the subcutaneous implanted port and catheter .6 4.7.1 Subcutaneous implanted ports not indicated for power injection .6 4.7.2 Subcutaneous implanted ports indicated for power injection. .6 5 Magnetic Resonance Imaging (MRI) compatibility ..6 6 Information to be supplied by the manufacturer .6 6.1 Marking on the device .6 6.2 Primary packaging. .6 6.3 Labels for traceability .7 6.4 Instruction for use. .7 Annex A (normative) Test method for freedom from air leakage .8 Annex B (informative) Determination of flushing volume .10 Annex C (informative) Guidance on further characterization testing: Needle penetration and withdrawal. ..12 Annex D (normative) Test method for freedom from leakage after multiple punctures ..14 AnnexE (normative) Peaktensileforce ..15 Bibliography .16 iii ndardization 5956617 thout license from IHS