ISO INTERNATIONAL STANDARD 15747 Third edition 2018-09 Plastic containers for intravenous injections Recipients en plastique pour injections intraveineuses Referencenumber IS015747:2018(E) so @IS02018 IS015747:2018(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2018 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 orIso's memberbody in the countryof therequester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax:+41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS015747:2018(E) Contents Page Foreword ..iv 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 Requirements .2 4.1 Physical requirements. .2 4.1.1 Manufacturing process compatibility .3 4.1.2 Resistance to temperature,pressure and leakage 3 4.1.3 Resistance to dropping .3 4.1.4 Transparency. 3 4.1.5 Water vapour permeability .3 4.1.6 Particulate contamination 3 4.1.7 Cover. .3 4.1.8 Access port -Penetration ability of the insertion point .3 4.1.9 Access port - Adhesion strength of the infusion device and impermeabilityoftheinsertionpoint 4.1.10 Accessport-Tightness oftheinjectionpoint 4 4.1.11 Hanger. .4 4.1.12 Identification 4 4.2 Chemical requirements. .4 4.2.1 Requirements for the raw container or the sheeting 4 4.2.2 Requirements forthetestfluid .4 4.3 Biological requirements .5 4.3.1 Impermeabilityfor microorganisms .5 4.3.2 Migration. .5 5 Application of tests. .5 Annex A (normative) Physical tests AnnexB(normative)Chemicaltests ..9 Annex C (normative) Biological tests ..12 AnnexD(normative)Referencespike .14 Bibliography .16 @ IS0 2018 -All rights reserved iii