ISO INTERNATIONAL STANDARD 11070 Secondedition 2014-11-01 Sterile single-use intravascular introducers, dilators and guidewires Introducteurs, dilatateurs et guides intravasculaires steriles non réutilisables Reference number IS011070:2014(E) ISO @IS02014 sefrom IHS IS011070:2014(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2014 All rights reserved. Unless otherwise specified, 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. ISOcopyrightoffice Casepostale 56.CH-1211Geneva20 Tel. +4122 749 0111 Fax+41227490947 E-mail [email protected] Web www.iso.org Published in Switzerland ii @IS0 2014-All rights reserved Provided by IHS 44001,Uersharabian, shahrams No reproduction or networking permited without license from IHS NotforResale, 11/09/2014 06:12:01MS IS0 11070:2014(E) Contents Page Foreword ..V Introduction.. ...vi 1 Scope.. 2 Normativereferences 3 Terms and definitions 4 Generalrequirements .5 4.1 Sterilization .5 4.2 Biocompatibility .5 4.3 Surface .5 Corrosion resistance .5 4.4 4.5 Radio-detectability .5 4.6 Information to be supplied by the manufacturer. .5 5 Additionalrequirementsforintroducerneedles .6 5.1 General 6 5.2 Sizedesignation .6 5.3 Needle point. .6 5.4 Hub .6 5.5 Information tobe supplied by the manufacturer. .6 6 Additionalrequirementsforintroducercatheters .6 6.1 General .6 6.2 Tip .7 6.3 Peaktensileforce .7 6.4 Hub 6.5 Size designation 1 6.6 Informationtobesuppliedbythemanufacturer ..8 7 Additional requirements for sheath introducers 7.1 General .8 7.2 Sizedesignation .8 7.3 Freedomfromleakage from sheath introducer .8 7.4 Freedom from leakage through haemostasis valve ..8 7.5 Hub 8 7.6 Peaktensileforce .8 7.7 Information to be supplied by the manufacturer. ..8 8 Additionalrequirementsforguidewires .8 8.1 General. .8 8.2 Size designation .9 8.3 Safety wire .9 8.4 Fracture test ..9 8.5 Flexing test .9 8.6 Peaktensileforceofguidewire 8.7 Information tobesupplied by the manufacturer .10 9 Additionalrequirementsfordilators .10 9.1 General. .10 9.2 Size designation ..10 9.3 Hub. .10 9.4 Informationto be supplied bythemanufacturer. ..10 10 Additional requirementsforkits containing combinations of devices specified in this International Standard .10 AnnexA (informative)Guidanceonmaterials anddesign .12 @ IS0 2014 -All rights reserved iii r networking permited without license from IHS Not for Resale, 11/09/2014 06:12:01 MS