ISO INTERNATIONAL STANDARD 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment Oropharyngeal airways Matériel d'anesthésie et de réanimation respiratoire - Canules oropharyngées Reference number ISO 5364:2016(E) ISO @ IS0 2016 IS0 5364:2016(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 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 [email protected] www.iso.org IS02016-Allrightsreserved IS05364:2016(E) Contents Page Foreword ..iv Introduction. 1 Scope. 2 Normative references ..1 3 Terms and definitions ..1 4 Size designation and dimensions. .2 4.1 .2 Size designation 4.2 Dimensions. .3 5 Materials .3 6 Design .3 7 Performance requirements .3 7.1 Resistance to collapse of the buccal portion .3 7.2 Patency of lumen. .3 8 Sterility assurance ..4 9 Packaging of oropharyngeal airways supplied sterile ..4 10 Marking ..4 10.1 General 4 10.2 Use of symbols. ..4 10.3 Marking of oropharyngeal airways .4 10.4 Marking of unit packs. ..5 10.5 Marking of shelf or multi-unit packs ..6 11 Information to be supplied by the manufacturer .1 AnnexA(informative)Rationale Annex B (normative) Test method for resistance to collapse of the buccal portion ..9 Annex C (normative) Test method for patency of lumen ..11 Annex D (informative) Guidance on materials and design ..13 Bibliography .14 CopyightIntemational orgzSaaraizAlrights reserved iii