ISO INTERNATIONAL STANDARD 11608-7 First edition 2016-08-01 Needle-based injection systems for medical use Requirements and test methods - Part 7: Accessibility for persons with visual impairment Systemes d'injection aaiguillepourusagemedical-Exigences et méthodes d'essai Partie7:Accessibilitepourlespersonnesmalvoyantes Reference number IS0 11608-7:2016(E) ISO @ ISO 2016 ntermational Organization for Standardization rovided by IHS under I e with ISC IS011608-7:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, 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 Provided by IHS under networking permited without licanse from IHS IS0 11608-7:2016(E) Contents Page Foreword ..iv Introduction. .. 1 Scope. 2 Normative references 3 Terms and definitions ..2 4 .3 Requirements 4.1 Riskanalysisrequirements .3 .3 4.2 General requirements 4.2.1 NIS design .3 4.2.2 Packaging design. .4 Test methods .4 5 5.1 Verification testing. .4 5.2 Summativeevaluation (validationtesting) 5.2.1 General. .5 5.2.2 User populations. .5 5.2.3 Context ofuse. .5 6 Test report 1.5 7 Information supplied bythe manufacturer .6 7.1 General ..6 Overview. 7.1.1 .6 7.1.2 Tactile information. .6 7.1.3 Auditory information 6 7.1.4 Informationprovidedinelectronicformat .6 7.2 Marking .6 7.2.1 Marking on the NIS 6 .7 7.2.2 Marking on theunit packaging 7.3 Instructions for use. .7 Annex A (informative) Measuring vision and visual impairment: Functional vision and visual acuity AnnexB (informative)Guidancefordeveloping instructions foruseforpersons with visual impairment. .13 Annex C (informative) Process for establishinga specification, test methods and verification related to 5.1 .15 ..18 Bibliography ili without license from IHS