ISO INTERNATIONAL STANDARD 17664 Second edition 2017-10 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux a fournir par le fabricant du dispositif Reference number IS0 17664:2017(E) Tso @ IS0 2017 IS0 17664:2017(E) COPYRIGHT PROTECTED DOCUMENT @ IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, 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 Ch. de Blandonnet 8 · CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org ii @ IS0 2017 - All rights reserved IS0 17664:2017(E) Contents Page Foreword iv Introduction. 1 Scope. 2 Normative references 3 Terms and definitions 2 4 Validation of the processes identified in the information provided by the medical device manufacturer 5 5 Risk analysis 5 6 Information to be provided by the medical device manufacturer 6 6.1 General 6 6.2 Processing instructions 6 6.3 Limitations and restrictions on processing. 6 6.4 Initial treatment at the point of use. 6.5 Preparation before cleaning. Cleaning 6.6 6.6.1 General Automated cleaning 6.6.2 6.6.3 Manual cleaning. 8 Disinfection. 6.7 9 6.7.1 General 9 6.7.2 Automated disinfection 9 Manual disinfection 6.7.3 9 6.8 Drying 10 6.9 Inspection and maintenance. .10 Packaging 6.10 10 6.11 Sterilization 11 Storage 6.12 11 .11 6.13 Transportation 7 Presentation of the information .12 .13 Annex A (informative) Commonly utilized processing methods. Annex B (informative) Example of processing instructions for reusable medical devices ..18 Annex C (informative) Classification of medical devices. .20 Annex D (informative) Additional guidance on information to be provided by the medical device manufacturer 23 Bibliography .24 iii IS0 2017 - All rights reserved IS0 17664:2017(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through IsO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with IsO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of IsO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISo list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of IsO specific terms and expressions related to conformity assessment, as well as information about Iso's adherence to th