ISO INTERNATIONAL STANDARD 18113-5 Second edition 2022-10 In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing Dispositifs medicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) Partie 5: Instruments de diagnostic in vitro destinés aux autodiagnostics Reference number IS0 18113-5:2022(E) ISO @ISO2022 IS0 18113-5:2022(E) COPYRIGHT PROTECTED DOCUMENT @ISO2022 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, withoutpriorwrittenpermission.Permission can berequestedfrom eitherIso at theaddress below orIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2022 - All rights reserved