IEC IEC/TR 80002-1 Edition 1.02009-09 TECHNICAL REPORT colour inside Medicaldevicesoftware- Part 1: Guidance on the application of ISO 14971 to medical device software IEC/TR80002-1:2009(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright @ 2009 IEC, Geneva, Switzerland or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, IEC Central Office 3, rue de Varembé CH-1211 Geneva 20 Switzerland Email: [email protected] Web: www.iec.ch About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. • Catalogue of IEC publications: www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee...). It also gives information on projects, withdrawn and replaced publications. IECJustPublished:www.iec.ch/onlinenews/iustpub Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by email. - Electropedia: www.electropedia.org The world's leading online dictionary of electronic and electrical terms containing more than 20 o00 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. : Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: [email protected] Tel.:+41229190211 Fax:+41229190300 IEC ISO IEC/TR 80002-1 Edition 1.02009-09 TECHNICAL REPORT colour inside Medicaldevicesoftware- Part 1: Guidance on the application of ISO 14971 to medical device software INTERNATIONAL ELECTROTECHNICAL COMMISSION PRICE CODE ICS11.040.01 ISBN 2-8318-1061-9