International ISO Standard ISO6559 First edition Traditional Chinese medicine Sterile three-edge needle for 2024-07 single use Medecine traditionnelle chinoise-Aiguille sterile d trois bords d usageunique Reference number IS0 6559:2024(en) ISO2024 IS0 6559:2024(en) COPYRIGHTPROTECTEDDOCUMENT @ISO2024 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 anyform or byanymeans, electronic ormechanical, including photocopying,or posting on orIso's memberbody in the country of therequester. ISo copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 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 Scope. 1 2 Normativereferences. 3 Terms anddefinitions 4 Specifications.. 4.1 Configuration. 4.2 Dimensionsandparameters. 4.2.1 Wholelengthofthethree-edgeneedle 4.2.2 Length of the head ofthethree-edge needle. 4.2.3 External diameter ofthe widest part ofthehead ofthethree-edge needle.. 4.2.4 External diameter ofthe body ofthethree-edge needle... 4.3 Material.. 5 Requirements. 5.1 Hardness.. 5.2 Roughness... 5.3 Puncture force. 5.4 Corrosion resistance.. 5.5 Sterilityassurance 5.6 Biological compatibility 5.7 Appearance quality. Packaging.... 6 6.1 Primary package. 6.2 Secondary package Labelling. 7 7.1 General 7.2 Primary package. 7.3 Secondary package 8 Transit and storage. AnnexA(informative)Testmethodforpunctureforce Bibliography @ IS0 2024 - All rights reserved ili