ISO INTERNATIONAL STANDARD 16971 First edition 2015-04-15 Ophthalmic instruments Optical coherence tomograph for the posterior segment of the human eye Instrumentsophtalmigues-Tomographea cohérenceoptiguedu segment postérieur de I'oeil humain Reference number ISO 16971:2015(E) SO International Organization for Standardization @ IS0 2015 andardization5956617 vided by IHS under itted without license from IHS IS0 16971:2015(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2015 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISOcopyrightoffice Case postale 56:CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland Prganizationfor Standardization Not for Resale, 2015/6/29 08:45:52 networking permitted without license from IHS IS0 16971:2015(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Normative references ..1 3 Terms and definitions 4 Requirements .3 4.1 General .3 4.1.1 General requirements. .3 4.1.2 Light hazard protection .3 4.2 Retinal thickness measurement. ..3 4.2.1 General .3 4.2.2 Presentation of retinal thickness maps. 4.3 Angular field of view 4 4.4 Depth scaling .4 4.5 Image quality 4 4.6 Axial resolution. .4 4.7 Signal-to-noise ratio (SNR) ..4 4.8 Calibration co-alignment of fundus image and OcT scan .4 4.9 Normative database. ..4 4.10 Data export. .5 5 Test methods. 5.1 General. .5 5.2 Testdevice .5 5.3 Co-alignment of preview and OcT scan. ..6 5.3.1 Test device .6 5.3.2 Procedure. ..6 5.4 Retinal thickness measurement .. 6 Information to be supplied by the manufacturer 1 6 7 Marking ..7 Annex A (informative) Minimum requirements for a normative database ..8 Bibliography 9 iii vided by IHS under lic cense with ISt vithout license from IHS Not for Resale, 2015/6/29 08:45:52