ISO INTERNATIONAL STANDARD 5366 Firstedition 2016-10-01 Anaesthetic and respiratory equipment Tracheostomy tubes and connectors Materiel d'anesthésie et de reanimation respiratoire-Raccords et tubesdetrachéostomie Reference number ISO 5366:2016(E) ISO Intemational Organization for Standardization @ISO2016 itted without license from IHS IS05366:2016(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. ISOcopyrightoffice 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 No reproduction or r networking permited without license from IHS IS0 5366:2016(E) Contents Page Foreword ..iv Introduction.. .. 1 *Scope 2 Normative references .... 3 Terms and definitions 4 *General requirements for TRACHEoSTOMY TUBES and connectors 5 Materials .4 6 DesignrequirementsforTRAcHEoSToMYTUBESandconnectors ..4 6.1 Generaldesignrequirements ..4 6.2 Size designation and dimensions .4 6.2.1 *Designated size. .4 6.2.2 Outside dimension .5 6.2.3 NOMINAL LENGTH. .5 6.3 Design .5 6.3.1 Connector .5 6.3.2 NECK PLATE .6 6.3.3 INNERTUBE 6 6.3.4 *CUFFS .7 6.3.5 INFLATINGTUBESfor CUFFS .7 6.3.6 CUFFINFLATIONINDICATOR .7 6.3.7 *INFLATING TUBE. .7 6.3.8 PATIENT END ..8 6.3.9 INTRODUCER. ..8 6.3.10 *Radiopaque marker .8 6.3.11 *Kink resistance. ..8 Requirements for TRACHEOSTOMY TUBES supplied sterile 7.1 Sterilityassurance. ..8 7.2 PackagingforTRACHEOSTOMYTUBESsupplied sterile .9 8 Information supplied by the manufacturer .9 8.1 General 9 8.2 MarkingofNECK-PLATE .9 8.3 MarkingontheINFLATIONINDICATOR .9 8.4 Marking of TRACHEoSTOMY TUBE connectors ..10 8.5 Additional labelling of unit packs .10 8.6 LabellingofINNERTUBEunitpacks .10 8.7 Labelling ofTRACHEOSTOMY TUBE inserts ..10 Annex A (informative) Rationale .12 Annex B (normative) Test method for the security of attachment of a fitted connector and NECK-PLATEtotheTRACHEOSTOMYTUBE .14 AnnexC (normative)TestmethodfordeterminingthediameterofthecUFF ..16 AnnexD(normative)TestmethodforcUFFherniation ..17 AnnexE (normative)Testmethodfordeterminingkinkresistance ..19 Annex F (informative) Guidance on materials and design ..21 AnnexG(informative)Hazardidentificationforriskassessment ..22 Bibliography ..25 ntemaional oganzation@S216-All rights reserved iii ithout license from IHS