ISO/TR TECHNICAL REPORT 24971 Second edition 2020-06 Medical devices Guidance on the application of IS0 14971 Dispositifs medicaux-Recommandations relativesaI'application de I'IS014971 Referencenumber IS0/TR24971:2020(E) OS1 @ISO2020 IS0/TR24971:2020(E) COPYRIGHTPROTECTEDDOCUMENT ISO2020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 below or ISo's memberbody in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122749 0111 Email:copyright@iso.org Website: www.iso.org Published in Switzerland i @ IS0 2020-All rights reserved

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