ISO INTERNATIONAL STANDARD 18113-4 Secondedition 2022-10 In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self- testing Dispositifs medicaux de diagnostic in vitro Informations fournies par le fabricant (étiquetage) Partie 4: Réactifs de diagnostic in vitro destinés aux autodiagnostics Reference number ISO 18113-4:2022(E) ISO @ ISO 2022 IS0 18113-4:2022(E) COPYRIGHTPROTECTEDDOCUMENT @IS02022 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 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: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2022 - All rights reserved