ISO INTERNATIONAL STANDARD 5359 Fourth edition 2014-10-01 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases Matériel d'anesthésie et de réanimation respiratoire - Flexibles de raccordement a basse pression pour utilisation avec les gaz medicaux Reference number ISO 5359:2014(E) @ IS0 2014 HS under Not for Resale IS0 5359:2014(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2014 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 copyrightoffice Case postale 56:CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland @ IS0 2014 - All rights reserved No reproductic networking permited without license from HS Not for Resale IS0 5359:2014(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. .1 2 Normative references 3 Terms and definitions ..2 4 General requirements ..6 4.1 Risk management. .6 4.2 Usability .6 4.3 Clinical investigation .6 4.4 Safety ..6 4.5 Materials. 7 4.6 Design requirements 4.7 Constructional requirements .10 5 Test methods. .11 5.1 General 11 5.2 Test method for pressure drop .11 5.3 Test method for leakage .11 5.4 Test method for gas specificity. 11 5.5 Test method for mechanical strength. .11 5.6 Test method for deformation under pressure ..12 5.7 Test method for resistance to occlusion. .12 5.8 Test method for durability of markings and colour coding. ..13 6 Marking, colour coding and packaging .13 6.1 Marking ..13 6.2 Colour coding .14 6.3 Packaging. .15 7 Information to be supplied by the manufacturer ..15 Annex A (informative) Rationale ..17 Annex B (informative) Environmental aspects ..18 Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases... .19 Bibliography .21 iii se with ISi withoutlicense from IHS Not for Resale