ISO INTERNATIONAL STANDARD 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin Seringues a insuline, steriles, non reutilisables, avec ou sans aiguille Reference number IS0 8537:2016(E) ISO International Organization for Standardization =ZHEJIANG INST OF STANDARDIZATION C1 5956617 @IS02016 vided by IHS under lic itted without license from IHS IS0 8537:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS02016,PublishedinSwitzerland 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 copyrightoffice 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 Intenationaibr PrganizationforStandardization icensee-ZHEJIANG INST OF STANDARDIZoISQ s.6 - All rights reserved etworking permitted without license from IHS IS0 8537:2016(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope 2 Normative references 3 Terms and definitions 4 Types of syringes. .5 5 Requirements .5 5.1 General requirements .5 5.2 Material selection.. ..6 5.3 Colour coding .6 5.4 Extraneous matter 5.4.1 General. .7 5.4.2 Limits for acidity or alkalinity .7 5.4.3 Limits for extractable metals. 7 5.5 Lubrication .7 5.5.1 Lubrication of syringes. .1 5.5.2 Lubrication of needle tube .8 5.6 Dimensions. .8 5.6.1 Barrel and plunger stopper .8 5.6.2 Finger grips. 5.7 Plunger/plunger stopper. .8 5.7.1 General 5.7.2 Fit of plunger stopper in barrel. .8 5.8 Nozzle. ..8 5.8.1 Conical fitting. ..8 5.8.2 Position of nozzle on end of barrel ..8 5.9 Needle tubing and needles.. 9 5.9.1 Needles for syringe types 3 and 4 9 5.9.2 Needle tubing for syringe types 5, 6, 7 and 8 .9 5.9.3 Bond between hub and needle tube .9 5.10 Standard test environmental conditions. 5.11 Performance of assembled syringe .9 5.11.1 Dead space. 5.11.2 Freedom from leakage at needle .10 5.11.3 Freedom from leakage past plunger stopper ..10 Packaging ..10 6 6.1 Unit packaging and self-contained syringe units ..10 6.1.1 General ..10 6.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7) ..10 6.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8) .10 6.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8) ..11 6.3 User packaging 11 7 Information supplied by the manufacturer .11 7.1 General 11 7.2 Syringes. 11 7.2.1 General. 11 7.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8) ..12 7.3 Unit packaging (for syringe types 1, 3, 5 and 7) 12 7.4 Multiple unit packs (syringe types 2, 4, 6 and 8) ..12 7.5 User packaging .13 7.6 Storage container. .14 7.7. Transport wrapping .14 iii Isee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 vided by IHS under license with ISO ed withoutlicense from IHS Not for Resale, 2016/6/2 08:40:16