ISO INTERNATIONAL STANDARD 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use Requirements and test methods Aiguilles hypodermiques steriles, non réutilisables - Exigences et méthodes d'essai Reference number ISO 7864:2016(E) ISO International Organization for Standardization @IS02016 mitted without license from IHS IS0 7864:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, Published in Switzerland 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 Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Internatinir DrganizationforStandardization networking permited without license from IHS IS0 7864:2016(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 Requirements .2 4.1 General. .2 4.2 Statistics and reproducibility of test methods. .2 4.3 Cleanliness. .2 .2 4.4 Limits for acidity or alkalinity 4.5 Limits for extractable metals. 2 4.6 Size designation .3 4.6.1 Tubular needle designation 3 4.6.2 Tapered needle designation. .3 4.7 Colour coding 4 4.8 Needle hub .4 4.8.1 Conical fitting .4 4.8.2 Colour of hub .4 4.9 Needle cap. ..4 4.10 Needle tube .5 4.10.1 General ..5 4.10.2 Tolerances on length 5 4.10.3 Freedom from defects. .6 4.10.4 Lubricant. .6 4.11 Needle point .6 4.12 Bond between hub and needle tube .7 4.13 Patency of lumen. .8 4.14 Sharps injury protection. ..9 4.15 Sterility and biocompatibility .9 4.15.1 Sterility ..9 4.15.2 Biocompatibility .9 5 Packaging .9 5.1 Unit packaging. 5.2 User packaging. .10 6 Information supplied by the manufacturer ..10 6.1 General .10 6.2 Unit packaging .10 6.3 User packaging ..10 6.4 Storage container. ..11 6.5 Transport wrapping .12 Annex A (normative) Method for preparation of extracts ..13 Annex B (informative) Fragmentation test for medical needles ..14 Annex C (informative) Determination of flow rate through the needle ..16 Annex D (informative) Test method for measuring the penetration force and drag force forneedles. ..18 Annex E (informative) Needle bonding strength test method ..22 Bibliography ..24 iii ed without license from IHS