ISO INTERNATIONAL STANDARD 7886-4 Second edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature Seringueshypodermiques stériles,nonreutilisables- Partie 4: Seringues avec dispositifempechant la reutilisation Reference number IS0 7886-4:2018(E) ISO @IS0 2018 IS0 7886-4:2018(E) COPYRIGHTPROTECTEDDOCUMENT IS02018 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 below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+4122749 0111 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS07886-4:2018(E) Contents Page Foreword ..V Introduction. ..vi 1 Scope. 2 Normative references 3 Terms and definitions .2 4 Types of syringe. 4.1 General. .2 4.2 Types of re-use prevention feature .2 4.3 Typesofintendeduse/application. .2 5 Extraneous matter .2 5.1 ..2 General 5.2 Limits for acidity or alkalinity .2 5.3 Limitsfor extractable metals .2 6 Lubricant. 7 Tolerance on graduated capacity ..3 8 Graduated scale .3 8.1 Scale. .3 ..3 8.2 Numbering of scale .3 8.3 Position of scale 8.4 Overall length of scale to nominal capacity line .3 9 Barrel. ..3 9.1 Dimensions. .3 .3 9.2 Barrel flanges 10 Plunger stopper/plunger assembly ..3 10.1 Design .3 10.2 Fit of plunger stopper/plunger in the barrel 10.3 Fiducial line .4 11 Syringe nozzle/needle .4 11.1 Syringe with integrated needle 11.2 Syringe with Luer nozzle. .4 12 Performance. .4 12.1 Dead space. .4 12.2 Freedomfrom air and liquid leakage 4 12.3 Re-usepreventionfeature. .5 12.4 Performance after shipping .5 13 Packaging. .5 13.1 Unit packaging and self-contained syringe units .5 13.2 Multiple unit pack. .5 13.3 User packaging .5 14 Information supplied by the manufacturer .5 14.1 5 General 14.2 Syringes 5 .5 14.2.1 General. 14.2.2 Unit packaging .5 14.3 Multiple unit packs .6 14.3.1 General. .6 14.3.2 Multiple unit packs with self-contained syringes. ..6 14.4 User packaging. .6 @ IS0 2018 - All rights reserved iii