ISO INTERNATIONAL STANDARD 17664-2 First edition 2021-02 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices Traitementdeproduitsdesoinsdesanté-Informationsrelatives autraitementdesdispositifsmedicauxa fournirparlefabricantdu dispositif- Partie 2: Dispositifs medicaux non critiques Reference number ISO 17664-2:2021(E) ISO @ ISO 2021 IS017664-2:2021(E) COPYRIGHTPROTECTEDDOCUMENT IS02021 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 ofthe requester. ISO copyright office CP 40i : Ch.de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22.749 01 11 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2021 - All rights reserved IS0 17664-2:2021(E) Contents Page Foreword ..iv Introduction ..V 1 Scope. ..1 2 Normativereferences ..1 3 Terms and definitions ..2 4 Risk analysis. ..4 5 Validationoftheprocessesidentifiedintheinformationprovidedbythemedical .5 device manufacturer 6 Information to be provided by the medical device manufacturer .5 5 6.1 General 6.2 .6 Processinginstructions 6.3 Limitationsandrestrictionsonprocessing 7 6.4 .7 Preparationbeforeprocessing 6.5 Cleaning .7 6.5.1 General 7 6.5.2 Manual cleaning. 7 6.5.3 Automated cleaning 8 6.6 Disinfection .8 6.6.1 General .8 6.6.2 Manual disinfection .8 6.6.3 Automateddisinfection 9 6.7 Drying .9 6.8 Inspectionandmaintenance. .9 6.9 Packaging. .10 6.10 Storage .10 6.11 Transportation .10 7 Presentationoftheinformation ..10 AnnexA(informative)Commonlyutilizedprocessingmethods .11 Annex B (informative) Example processing instructionsfor non-critical reusable medical ..15 devices. AnnexC (informative) Processing classification and grouping ofmedical devices ..17 AnnexD (informative)Additional guidance on information tobeprovided bythemedical device manufacturer .19 AnnexE (informative) Examples ofmedical devices and theirrelationshiptothis document ...20 Bibliography .24 IS0 2021-All rights reserved ili