International ISO Standard ISO6559 First edition Traditional Chinese medicine - 2024-07 Sterile three-edge needle for single use Medecine traditionnelle chinoise - Aiguille stérile a trois bords a usage unique Reference number IS0 6559:2024(en) @ISO2024 IS0 6559:2024(en) COPYRIGHT PROTECTED DOCUMENT IS02024 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 or Iso's memberbody inthe country ofthe requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Email: [email protected] Website: www.iso.org Published in Switzerland @ IS0 2024 - All rights reserved ii IS0 6559:2024(en) Contents Page Foreword .iv Introduction .V 1 Scope .1 .1 2 Normative references 3 Terms and definitions .1 .2 4 Specifications. 4.1 Configuration .2 4.2 Dimensions and parameters .3 Whole length of the three-edge needle. ..3 4.2.1 Length of the head of the three-edge needle 4.2.2 .3 4.2.3 External diameter of the widest part of the head of the three-edge needle .3 4.2.4 External diameter of the body of the three-edge needle ..3 4.3 Material.. .4 5 Requirements. 5.1 Hardness. .4 5.2 ..4 Roughness 5.3 .4 Puncture force 5.4 Corrosion resistance .4 ..4 5.5 Sterility assurance 5.6 Biological compatibility .4 5.7 Appearance quality Packaging. 5 6 .5 6.1 Primary package 6.2 Secondary package .5 Labelling .5 7 7.1 General .5 7.2 Primary package ..5 7.3 Secondary package .6 Transit and storage .6 8 .7 Annex A (informative) Test method for puncture force Bibliography 9 @ IS0 2024 - All rights reserved iii