ISO INTERNATIONAL STANDARD 80369-6 Firstedition 2016-03-15 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications Raccords destinésades applications en contact avec le systeme nerveux (neuraxiales)- Partie 6: Raccords destines a des applications en contact avec le systeme nerveux (neuraxiales) Reference number E( ISO 80369-6:2016(E) Ts Intemational Organization for Standardization @IS02016 See=ZHEJIANG INSTOFSTANDARDIZATIONC15956617 ed without license from IHS IS080369-6:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS02016,Published in Switzerland 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 copyright office Ch. de Blandonnet 8.CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +4122 749 09 47 copyright@iso.org www.iso.org Uicensee-ZHEJIANG INST OF STANDARDIZoISQ,6-All rights reserved etworking permitted without license from IHS Not for Resale, 2016/6/2 08:27:43 IS080369-6:2016(E) Contents Page Foreword ..iv Introduction. ..V 1 * Scope. ..1 2 Normative references ... 3 Terms and definitions ..2 4 Generalrequirements .3 4.1 General requirementsfortheneuraxialAPPLICATION. .3 4.2 *MaterialuSedfor SMALL-BORECONNECTORS ..4 4.3 TYPE TESTS. .4 5 Dimensionalrequirementsforneuraxial SMALL-BoREcoNNEcToRS .4 6 Performancerequirements .4 6.1 Fluid leakage .4 6.1.1 Fluid leakage requirement .4 6.1.2 Leakage by pressure decay .4 6.1.3 Positivepressureliquid leakage 4 6.2 Subatmosphericpressure airleakage. .5 6.3 Stress cracking .5 6.4 Resistance to separation from axial load. .5 6.5 Resistance to separation from unscrewing .5 6.6 Resistance to overriding .5 AnnexA (informative) Rationale and guidance ..6 AnnexB(normative)*SMALL-BORECoNNECTORSforneuraxialAPPLICATIONS ..11 AnnexC(normative)ReferencecoONNECTORSfortestingSMALL-BOREcoNNECTORSfor neuraxialAPPLICATIONS. .20 AnnexD (informative)Assessment ofMEDICALDEVICEs and theirattributeswith CONNECTIONS within thisAPPLICATION .26 Annex E (informative) Summary ofthe usabilityrequirements for SMALL-BORE coNNECTORS forneuraxialAPPLICATIONS .27 AnnexF(informative)SummaryofsMALL-BoREcoNNEcToRdesignrequirementsfor neuraxialAPPLICATIONS .30 AnnexG (informative)Summary ofassessment ofthedesignofthe SMALLBoREcoNNEcToRs forneuraxialAPPLICATIoNS .33 Annex H (normative) Mechanical tests for verifying NoN-INTERcoNNEcTABLE characteristics ..37 AnnexI (informative)Referencetotheessential principles. ..41 AnnexJ (informative)Terminology-alphabetized indexofdefined terms ..43 Bibliography ..44 iii =ZHEJIANG INSTOF STANDARDIZATIONC15956617 ut license from IHS