ISO INTERNATIONAL STANDARD 27186 Second edition 2020-11 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements Dispositifsmedicauxactifsimplantables-Systemesdebranchement aquatrepolespourdispositifs implantablesdegestion durythme cardiaque-Exigences de dimensions etd'essai Reference number IS0 27186:2020(E) IEC ISO2020 IS0 27186:2020(E) COPYRIGHTPROTECTEDDOCUMENT @IS02020 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 memberbody in the country ofthe requester. ISO copyright office CP 40i : Ch.de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22.749 01 11 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2020 - All rights reserved IS027186:2020(E) Contents Page Foreword ..V Introduction. .. i. 1 Scope. 2 Normative references 3 Terms and definitions 4 Requirements ..5 4.1 General .5 4.2 Lead connectorphysical requirements. ..5 Dimensions 4.2.1 .5 4.2.2 Materials .10 4.2.3 Lead connector electrical connections .10 4.2.4 Lead marking .10 4.2.5 Lead package labels and literature .12 4.3 Lead connectorfunctional requirements .12 4.3.1 Functional dimensional check. .12 4.3.2 .13 Tensile loads 4.3.3 Deformation due to pin contact forces ..13 4.3.4 Deformation due to ring contact forces .13 4.3.5 Seal zone requirement ..14 4.3.6 Electrical isolation requirement .14 4.3.7 Dielectric strength requirement .15 4.3.8 Current-carrying requirement. .15 4.3.9 ..15 Corrosion/environmental. 4.4 Connector cavity physical requirements .15 4.4.1 Dimensions .15 4.4.2 Connectorcavityelectrical connections. .18 4.4.3 Connectorcavity/pulsegeneratormarking .18 4.4.4 Pulse generator labels and literature ..19 4.5 Connector cavity functional requirements .19 4.5.1 Insertion force. .19 4.5.2 Retentionforce .20 4.5.3 Withdrawal force .21 4.5.4 Ring contact load. .21 4.5.5 Seal zone load requirement 22 4.5.6 Electrical isolation requirement 22 4.5.7 Dielectric strength requirement 22 4.5.8 Current-carrying requirement (high-voltage connector cavity) 22 4.5.9 Contactresistance/stability .22 Annex A (normative) Electrical isolation test .23 Annex B (informative) Rational for Annex A .28 AnnexC (normative)Dielectricstrengthtest .30 AnnexD (informative)RationalforAnnexC ..35 Annex E (normative)Current-carryingtest high-voltagetypes ..39 AnnexF(informative)RationalforAnnexE ..44 AnnexG (informative)Leadconnectorfatiguestrengthtest. ..46 Annex H (informative) Lead connector seal zone materials ..47 Annex I (informative) Seal zone creep .49 AnnexJ (informative)Contactresistancestability .54 @ IS0 2020 - All rights reserved ii
ISO 27186 2020 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements
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