ISO INTERNATIONAL STANDARD 17218 First edition 2014-02-01 Sterile acupuncture needles for single use Aiguilles d'acupuncture stériles a usage unique Reference number IS0 17218:2014(E) ISO @IS02014 I by IHS under n or networking permitted without license from IHS Not for Resale IS0 17218:2014(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. ISO copyright office Case postale 56 : CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax +41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IS0 2014 - All rights reserved No reproduction or networking permited without license from IHS Not for Resale IS0 17218:2014(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions ..1 4 Configuration .2 4.1 Acupuncture needle configuration .2 4.2 Acupunctureneedletypes. .2 4.3 Types of needle handles. .3 5 Requirements .5 5.1 Materials 5 5.2 Dimensions 5 5.3 Performancerequirements 7 5.4 Sterility assurance 9 6 Package. .9 6.1 Primary package 9 6.2 Secondary package 10 7 Labelling. .10 7.1 General 10 7.2 Primary package ..10 7.3 Secondary package .10 8 Transit and storage ..11 Annex A (informative) Test methods for the intensity and sharpness of the tip of the needle... ....12 Annex B (informative) Test methods for the puncture performance of the tip of the needle... ..16. Annex C (informative) Test method for resistance to corrosion ..21 Bibliography ..23 ii ithout license from IHS Not for Resale