ISO INTERNATIONAL STANDARD 17510 First edition 2015-08-01 MedicaldevicesSleepapnoea breathingtherapy-Masksand applicationaccessories Dispositifs medicaux-Therapierespiratoire deI'apneedu sommeil Masquesetaccessoiresd'application Referencenumber ISO17510:2015(E) ISO2015 IS017510:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS02015,Published inSwitzerland 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 bocdy in the country of the requester. 1S0 copyright office Ch.deBlandonnet8-CP 401 CH-1214 Vernier, Geneva, Switzerland Tel.+4122 749 0111 Fax +41227490947 [email protected] www.jso.org tNrRe6e.2815/102207:38.156 IS017510:2015(E) Contents Page Foreword iv Introduction 1 Scope, .1 2 Normativereferences -1 2 3 Terms anddefinitions 3 4 Informationtobe suppliedbytheMANUFACTURER 4.1 General. 3 4.2 Markingon theprotectivepackaging 3 4.3 ACCOMPANYINGDOCUMENT 4 5 5 Construction requirements 5.1 5 MAsk connectors 5 5.2 Biocompatibility 5.3 Protectionagainst REBREATHING.. 6 5.3.1 NoRMALCONDITIONprotection 6 5.3.2 SINGLEFAULTCONDITIONPROTECTION 6 5.4 CLEANING, DISINFECTION,and sterilization 6 1 5.5 Breathing during SINGLE FAULT CONDITION 5.6 Breathing systemfilter. .7 Vibration and noise .7 6 Annex A (informative) Particular guidance and rationale 8 Annex B (normative)ExHAusTFLowtestprocedure 12 AnnexC (normative) Resistancetoflow (pressuredrop) 14 AnnexD(normative)ANTi-ASPHYxIAVALVEpressuretesting 16 AnnexE (normative) Determination ofthe inspiratory and expiratory resistance under SINGLE FAULT CONDITION 18 AnnexF (normative)CarbonDioxideREBREATHING 20 AnnexG (normative)Vibration and noise. 23 AnnexH (informative) Guidetoinformationto be supplied bytheMANUFAcTURER 25 AnnexI(informative)Referencetotheessentialprinciples 26 Annex| (informative)Terminology-alphabetized indexofdefinedterms 28 Bibliography 30 ili ceiee hom HS IS017510:2015(E) Foreword ISo (the lInternational Organization for Standardization) is a worldwide federation ofnational standards bodies (isO member bodies).The work of preparing International Standards is normally carried out through Iso technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/lEC Directives, Part 1. In particular the different approval criteria needed for the different types of isO documents should be noted. This document was drafted in accordance with the editorialrules oftheIso/lEcDirectives,Part2 (seewwwiso.org/directives). 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on theIso list ofpatent declarations received (seewww.iso.org/patents). Any trade name used in this document is information given for the convenience ofusers and does not constitutean endorsement. assessment, as well as information about IsO's adherence to the WTO principles in the Technical BarrierstoTrade (TBT)seethefollowingURL:Foreword-Supplementary informatian The committee responsible for this document is Iso/T 121, Anaesthetic and respiratory equipment, Subcommittee SC3, Lung ventilators and related equipment. Thisfirstedition cancels andreplaces thesecondeditionofIS017510-2:2007whichhasbeentechnically revisedw