ISO/TS TECHNICAL SPECIFICATION 22218-1 First edition 2023-01 Health informatics Ophthalmic examination device data - Part 1: General examination devices Informatique de sante - Données relatives aux dispositifs d'examen ophtalmique- Partie 1: Dispositifs pour les examens genéraux Reference number IS0/TS 22218-1:2023(E) ISO @IS02023 IS0/TS 22218-1:2023(E) COPYRIGHT PROTECTED DOCUMENT @ IS0 2023 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 @IS02023-Allrightsreserved IS0/TS 22218-1:2023(E) Contents Page Foreword .iv Introduction .V 1 Scope 2 Normative references 3 Terms and definitions .1 4 Specifications .4 4.1 General. 4.2 deviceCDA and persistent examination reports 4.3 Data classification constitution in the file 5 4.4 OEDD structure. 4.4.1 General 4.4.2 Dataclassifications 4.4.3 Attribute value and classification. 7 4.4.4 Handling of common data. .7 4.4.5 Handling of ophthalmic examination data. .9 4.4.6 Handling of units of measurement. 11 4.5 OEDD XML schema.. 11 Annex A (informative) Ophthalmic examination data cases .12 Annex B (informative) Standard codes used for common data .13 AnnexC(informative)Standardcodesforophthalmicexaminationdata .14 Annex D (informative) Sample files .54 Bibliography 153 @ IS0 2023 - All rights reserved iii IS0/TS 22218-1:2023(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 throughIsotechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnical 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 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 constituteanendorsement. 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 World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html. This document was prepared by Technical Committee ISo/TC 215, Health informatics A list of all parts in the ISO 22218 series can be found on the ISO website. Any feedback or questions on this document should be directed to the user's national standards body. A complete listing of these bodies can be found at www.iso.org/members.html iv @ IS0 2023 - All rights reserved IS0/TS 22218-1:2023(E) Introduction Opthalmic devices are used in hospitals and clinics to conduct examinations for patients. The primary devices used in these opthalmic examinati