ISO INTERNATIONAL STANDARD 8835-7 First edition 2011-11-01 Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases Systemesd'anesthésieparinhalation- Partie 7:Systemes d'anesthésie pourutilisation dans deszones avec équipement logistique limite enélectriciteetengaz anesthesiques Reference number ISO 8835-7:2011(E) SO @ISO2011 ISO8835-7:2011(E) COPYRIGHTPROTECTEDDOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Casepostale56·CH-1211Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISo 2011 -All rights reserved ISO 8835-7:2011(E) Contents Page Foreword * Introduction. 1 *Scope 2 Normativereferences 3 Terms anddefinitions 4 General requirements.. 4.1 Electrical safety 4.2 Mechanical hazards 4.3 Risk management. 5 *Essential functions. 2 6 Oxygen concentrators 7 Performancerequirements 7.1 Electricalsupply 7.2 Gas supply ... 7.3 Flammableanaestheticagents 8 Construction requirements. 8.1 Servicing.. 8.2 Materials.. 9 Environmentalconditions 10 Marking. 11 Informationtobeprovidedbythemanufacturer AnnexA (informative)Rationale A.1 General A.2 IntroductionandClause5. A.3 Clause1 AnnexB (informative)Reference to theessential principles Bibliography ISO 8835-7:2011(E) Foreword Iso (the International Organization for Standardization) is a worldwide federation of national standards bodies technical committees. Each member body interested in a subject for which a technical committee has been non-governmental, in liaison with isO, also take part in the work. IsO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/lEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards International Standard requires approvalbyat least 75%of the memberbodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO 8835-7wasprepared by Technical Committee ISO/TC 121,Anaesthetic and respiratory equipment, Subcommittee Sc 1,Breathingattachmentsandanaestheticmachines. IsO8835consistsofthefollowingparts,underthegeneral titleInhalational anaesthesia systems: Part 7:Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases Thefollowingparts are withdrawn and replaced by ISO 80601-2-13: Part 2:Anaesthetic breathing systems Part3:Transferand receivingsystemsofactiveanaestheticgas scavenging systems Part 4:Anaestheticvapour deliverydevices Part5:Anaestheticventilators Draw-overvaporizersaredescribed inISO/Ts18835. ISO 8835-7:2011(E) * Introduction The World Health Organisation (WHO)and the World Federation of Societies of Anaesthesiologists (WFSA) areconcernedabouttheprovisionofsafeanaesthesia,usingappropriatelydesignedanaestheticequipment in the large numbers of countries in the world where economics or infrastructure leadto a situation where complex technology is unlikely to function well, if at all, and might introduce hazards of its own. A total of 152 countries have been identified where the infrastructure or economic restrictions prevent the use Equipment designed for use in these countries should meet the following minimum criteria: a) ability to function in the absence of a regular supply of compressed medical gases; b) abilityto continue to function saf