ISO INTERNATIONAL STANDARD 80369-3 First edition 2016-07-01 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés a des applications entérales Reference number IS0 80369-3:2016(E) ISO International Organization for Standardization -ZHEJIANG INST OF STANDARDIZATION C1 5956617 @ IS0 2016 ted without license from IHS IS0 80369-3:2016(E) COPYRIGHT PROTECTED DOCUMENT 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 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 copyright@iso.org www.iso.org Licensee-ZHEJIANG INST OF STANDARDIZoISQ6 -All rights reserved Not for Resale, 2016/8/16 08:33:12 No reproduction or networking permited without license from IHS IS0 80369-3:2016(E) Contents Page Foreword ..iv Introduction. .. 1 * Scope. ..1 2 Normative references 3 Terms and definitions ..2 4 General requirements .3 4.1 General requirements for the ENTERAL APPLICATION .3 4.2 MaterialuSed for ENTERAL SMALL-BORECONNECTORS. .3 4.3 TYPE TESTS. .4 5 Dimensional requirements for ENTERAL SMALL-BORE CONNECTORS .4 6 Performance requirements .4 6.1 Fluid leakage .4 6.1.1 Fluid leakage requirement .4 6.1.2 Leakage by pressure decay ..4 6.1.3 Positive pressure liquid leakage .4 6.2 Stresscracking .4 6.3 Resistance to separation from axial load 4 6.4 Resistance to separation from unscrewing ..5 6.5 Resistance to overriding ..5 6.6 Disconnection by unscrewing ..5 Annex A (informative) Rationale and guidance ..6 Annex B (normative) ENTERAL SMALL-BORE CONNECTORS ..10 AnnexC(normative)ReferencecoNNEcToRs .16 Annex D (informative) Assessment of MEDICAL DEVICEs and their attributes with CONNECTIONS within this APPLICATION .21 Annex E (informative) Summary of the usability requirements for SMALL-BoRE coNNEcToRS for ENTERAL applications. .22 Annex F (informative) Summary of sMALL-BoRE coNNEcToR criteria and requirements for ENTERALAPPLICATIONS .27 Annex G (informative) Summary of assessment of the design of the coNNEcToRs for ENTERALAPPLICATIONS ..30 Annex H (informative) Reference to the essential principles. ..36 Annex I (informative) Terminology - -Alphabetized index of defined terms. ..38 Bibliography .39 ii See=ZHEJIANG INST OF STANDARDIZATION C1 5956617 vithout license from IHS