ISO INTERNATIONAL STANDARD 11040-6 Secondedition 2019-01 Prefilled syringes Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling Seringues preremplies- Partie 6: Cylindres en plastique pour produits injectables et seringues preé-assemblées stérilisées préremplissables Reference number ISO 11040-6:2019(E) ISO @ IS0 2019 IS0 11040-6:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO 2019 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 member body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 11040-6:2019(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. .1 2 Normative references ...1. 3 Terms and definitions ..2 4 General requirements. .3 4.1 Quality systems. .3 4.2 Testing. .3 4.3 Documentation . .3 5 Dimensions and designation .4 5.1 Design including dimensions. 5.2 Design requirements .7 5.2.1 Head design .7 5.2.2 Dead space 7 5.2.3 Functional testing of Luer cone/Luerlock connection .7 5.2.4 Flange breakage resistance. .7 5.2.5 Syringe tip breakage resistance .7 6 Requirements .7 6.1 General .7 6.2 Material .8 6.2.1 General. .8 6.2.2 Duty of notification concerning modifications to polymers. ..8 6.2.3 Needle. ..8 6.2.4 Closure system 9 6.2.5 Closure system integrity 10 6.3 Physical requirements. .10 6.3.1 Sterilization ..10 6.3.2 Clarity and transparency .10 6.3.3 Particulate contamination .10 6.3.4 Lubricants. .11 6.4 Chemical requirements .11 6.5 Endotoxins and biological requirements .11 7 Graduation ..12 8 Packaging and labelling. .12 Annex A (informative) Examples of types of sterilized subassembled syringes ready for filling...13 Annex B (informative) Head designs ..16 Annex C (normative) Test methods for syringe barrels ..18 Annex D (informative) Sample preparation for endotoxin and particulate determination .24 Annex E (informative) Evaluation of syringe lubrication by glide force test method. .28 Annex F (informative) Needle penetration test. ..31 Annex G (normative) Test methods for syringe closure systems. .34 Annex H (informative) Dye solution tightness test ..49 Annex I (informative) Guidance on materials ..51 Bibliography .52 @ IS0 2019 - All rights reserved iii