ISO INTERNATIONAL STANDARD 18835 Firstedition 2015-04-01 Inhalational anaesthesia systems Draw-over anaesthetic systems Systemes d'anesthésie par inhalation - Alimentation en vapeur et équipements annexes Reference number ISO 18835:2015(E) ISO International Organization for Standardization Zhejiang Institute of Standardization 5956617 @IS02015 No reproduction or networking permitted without license from IHS IS0 18835:2015(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2015 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 Case postale 56:CH-1211 Geneva 20 Tel. +41 22 749 0111 Fax +4122 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland PrganizationforStandardization vided by IHS unde Not for Resale, 2015/6/29 08:34:08 etworking permitted without license from IHS IS0 18835:2015(E) Contents Page Foreword ..iv Introduction. ..V 1 * Scope. 2 Normative references 3 Terms and definitions 4 General requirements ..2 4.1 Risk management. .2 4.2 Construction .3 4.3 Performance .4 4.4 * Components for use with flammable anaesthetic agents 4.5 Materials. 4 4.6 Mechanical hazards. ..4 4.7 Particulatematter.. ..4 4.8 Environmental requirements ..4 DRAW-OVER VAPORIZER 5.1 Construction .5 5.2 Performance ..5 5.3 * Ports and connectors .6 6 Breathing system. ..6 6.1 Construction .6 6.2 Performance .7 6.3 Ports and connectors. .7 7 RESERVOIR .17 7.1 Construction .1 7.2 Performance .7 7.3 Ports and connectors. Bellows-type manual ventilator 8 8.1 * Construction. ..8 8.2 Performance 8.3 Portsandconnectors .9 9 Marking of operator-assembled components .9 9.1 General 9.2 Marking of the DRAW-OVER VAPORIZER. ..9 9.3 Marking of breathing-system attachments .10 9.4 Marking of RESERVOIR .10 9.5 Marking of bellows-type manual ventilator ..10 9.6 Marking of packages .11 10 Information supplied by the manufacturer ..11 AnnexA(informative)Rationale .13 Annex B (normative) Test methods ..15 Annex C (informative) Environmental aspects ..17 Annex D (informative) Reference to the essential principles ..18 Bibliography ..22 iii see=Zhejiang Institute of Standardization 5956617 ed without license from IHS