IEC ISO IEC82304-1 Edition 1.02016-10 INTERNATIONAL STANDARD NORME INTERNATIONALE colour inside Healthsoftware- Part1:General requirementsforproductsafety Logicielsdesante- Partie1:Exigences generales pourla securitedes produits IEC 82304-1:2016-10(en-fr) THISPUBLICATIONISCOPYRIGHTPROTECTED Copyright 2016IEC,Geneva,Switzerland All rights reserved.Unlessotherwise specified, nopart of thispublicationmaybe reproduced orutilized in anyform or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from eitherIEC or IEC's memberNational Committee in the country of the requester.If you have any questions about IEC yourlocal IECmemberNationalCommitteeforfurtherinformation. 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 deI'lEC devotrepaysde residence. IECCentralOffice Tel.:+41229190211 3, rue de Varembé 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 The technical content of IEC publications is kept under constant reviewby the IEC.Please make sure that you have the 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 containing 20 000 terms and definitions in Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional documents.AvailableforPC,MacOS,AndroidTabletsand languages. Also known as the International Electrotechnical iPad. 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 65 000 electrotechnical terminology entries in English and variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of committee,...). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been and withdrawn publications. collected from earlier publications of IEC TC 37, 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 monthby email. needfurtherassistance,pleasecontacttheCustomerService Centre:[email protected]. Apropos de I'IEc La Commission Electrotechnique Internationale (lEC)est la premiere organisation mondialequi élabore et publie des Normes internationales pour tout ce qui a trait a I'electricite, a '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 determesélectroniques et bibliographiques sur les Normes internationales, Specifications techniques, Rapports techniques et autres electriques.Il contient20 000 termes etdefinitions en anglais et en francais,ainsi que les termes équivalents dans 15 documents de I'lEC