INTERNATIONAL ISO/IEEE STANDARD 11073-10425 Second edition 2019-03 Health informatics Personal health device communication : Part 10425: Device specialization Continuous glucose monitor (CGM) Informatique de santé - Communication entre dispositifs de santé personnels Partie 10425: Spécialisation du dispositif- Glucometre continu (CGM) ISO Reference number IS0/IEEE11073-10425:2019(E) 3331@ @ IEEE 2018 IS0/IEEE 11073-10425:2019(E) COPYRIGHTPROTECTEDDOCUMENT IEEE2018 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 ontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromIEEEattheaddressbelow InstituteofElectricalandElectronicsEngineers,Inc 3 Park Avenue, New York NY10016-5997,USA Email: [email protected] Published in Switzerland ii @ IEEE 2018 - All rights reserved IS0/IEEE11073-10425:2019(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 (see www.iso.org/directives). IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards through a consensus development process, approved by the American National Standards Institute, which brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers are not necessarily members of the Institute and serve without compensation. While the IEEE administers the process and establishes rules to promote fairness in the consensus development process, the IEEE does not independently evaluate, test, or verify the accuracy of any of the information contained in its standards. Attention is drawn to the possibility that some of the elements of this document may be the subject 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 of 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 the see www.iso.org/iso/foreword.html. IS0/IEEE11073-10425 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10425-2017) and drafted in accordance with its editorial rules. It was adopted, under the “fast-track procedure" defined in the Partner Standards Development Organization cooperation agreement between IsO and IEEE, by Technical Committee ISO/TC 215, Health informatics. This second edition cancels and replaces the first edition (IS0/IEEE 11073-10425:2016), which has beentechnicallvrevised. A list of all parts in the IS0 11073 series can be found on the ISO website. Any feedback or questions on this document should be d