ISO INTERNATIONAL STANDARD 14971 Third edition 2019-12 Medical devices Application of risk management to medical devices Dispositifs médicaux - Application de la gestion des risques aux dispositifs medicaux Reference number IS0 14971:2019(E) TEC ISO @ IS0 2019 IS0 14971:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO 2019 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 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 body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved