IEC ISO IEC62366-1 Edition1.02015-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medicaldevices Part1:Applicationofusabilityengineeringtomedicaldevices Dispositifs medicaux- Partie 1:Application de I'ingenierie de l'aptitude a I'utilisation aux dispositifs medicaux IEC 62366-1:2015-02(en-fr) out license from IHS THISPUBLICATIONISCOPYRIGHTPROTECTED Copyright 2015IEC,Geneva,Switzerland All rights reserved.Unless otherwise specified, no part of thispublicationmay be reproduced orutilized in anyform or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from eitherIECorIEC'smemberNationalCommitteeinthecountryoftherequester.IfyouhaveanyquestionsaboutIEC yourlocalIECmemberNationalCommitteeforfurtherinformation. ni utilisee sousquelqueforme que ce soitet paraucun procede,électroniqueoumecanique,y compris la photocopie et les microfilms, sans I'accord écrit de I'EC ou du Comite national de IIEC du pays du demandeur. Si vous avez des questions sur le copyright de I'lEc ou si vous desirez obtenir des droits supplementaires sur cette publication, utilisez lescoordonneesci-apresoucontactezleComitenational deIl'lEC devotrepaysderesidence. IEC CentralOffice Tel.:+41229190211 3, rue de Varembe Fax:+41229190300 CH-1211 Geneva 20 [email protected] Switzerland www.iec.ch Aboutthe IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standardsforall electrical,electronicand relatedtechnologies. About IEC publications latestedition,acorrigendaoranamendmentmighthavebeenpublished IEc Catalogue -webstore.iec.ch/catalogue Electropedia-www.electropedia.org The stand-alone application for consulting theentire The world's leading online dictionary of electronic and bibliographical information on IEC International Standards, electrical terms containingmore than30000 terms and Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15 documents.AvailableforPC,MacOS,AndroidTabletsand additional languages. Also known as the International iPad. Electrotechnical Vocabulary(IEV)online. IEC publications search-www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in varietyof criteria (reference number, text, technical English and French extracted from the Terms and Definitions committee,...). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries and withdrawnpublications. havebeencollectedfromearlierpublicationsofIECTC37 77, 86 and CISPR. IEc Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published IEc Customer Service Centre -webstore.iec.ch/csc details all new publications released.Available online and If youwishtogiveusyourfeedbackonthispublicationor also once a month by email. needfurtherassistance,pleasecontacttheCustomerService Centre:[email protected]. Apropos de I'IEc La Commission Electrotechnique Internationale (lEC)est la premiere organisation mondiale qui élabore et publie des Normes internationales pour tout ce qui a trait a I'électricite, a i'electronique et aux technologies apparentees. AproposdespublicationsIEC LecontenutechniquedespublicationsIEC estconstamment revu.VeuillezvousassurerquevouspossédezI'éditionla plus recente,un corrigendum ouamendementpeutavoirétepublie. CatalogueIEC-webstore.iec.ch/catalogue Electropedia-www.electropedia.org Applicationautonomepourconsultertouslesrenseignements Le premier dictionnaire en ligne determes électroniques et bibliographiques sur les Normes internationales, Specifications techniques, Rapports techniques et autres electriques.Il contient plus de 30 000termes et definitions en anglais et en francais, ainsi queles termes equivalents dans documents de I'lEC.DisponiblepourPC,MacOS,tablettes 15 langues additionnelles