GUIDE 63 Third edition 2019-08 Guide to the development and inclusion of aspects of safety in International Standards for medical devices Guide pour I'élaboration des aspects de sécurité et leur incorporation dans des Normes internationales relatives aux dispositifs medicaux Reference number TEC IS0/IEC GUIDE 63:2019(E) Is @IS0/IEC 2019 IS0/IEC GUIDE 63:2019(E) COPYRIGHTPROTECTEDDOCUMENT @IS0/IEC 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-1214Vernier, Geneva Phone: +4122 749 0111 Fax: +4122 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland i @ IS0/IEC 2019 - All rights reserved