ISO INTERNATIONAL STANDARD 15621 Third edition 2017-06 Absorbent incontinence aids for urine and/or faeces General guidelines on evaluation Aides a I'incontinence pour I'absorption d'urine et/ou de matieres fécales-Directivesgéneralesd'évaluation Referencenumber IS015621:2017(E) Intemational Organization for Standardization @IS02017 =ZHEJIANG INSTOFSTANDARDIZATIONC15956617 ted without license from IHS IS0 15621:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS02017,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 +4122 749 09 47 [email protected] www.iso.org Uicensee-ZHEJIANG INSTOF STANDARDIZRoISQl.7 -All rights reserved etworking permitted without license from IHS Not for Resale, 2017/9/12 02:54:08 IS0 15621:2017(E) Contents Page Foreword ..iv Introduction.. 1 Scope. 2 Normative references 3 Terms and definitions 4 Evaluation requirements 4.1 General .4 4.2 User-relatedfactors ..4 4.2.1 General. .4 4.2.2 Qualityof life 4.2.3 Independence or assistance 4 4.2.4 Nature of incontinence .4 4.2.5 Endusercharacteristics 5 4.2.6 Activities .5 4.2.7 Individual needs .5 4.2.8 Handling products .6 4.3 Product-related factors. .6 4.3.1 General. .6 4.3.2 Freedom from leakage .6 4.3.3 Freedom from odourleakage 6 4.3.4 Skin health .7 4.3.5 Comfort and fit .7 4.3.6 Discretion. .7 4.4 Usage-related factors. .8 4.4.1 Ergonomics .8 4.4.2 Needs of carer. .8 4.4.3 Information supplied 8 4.4.4 Laundry facilities. ..8 4.4.5 Disposal facilities .8 4.4.6 Sustainabilityand environment 4.4.7 Productsafety 9 4.4.8 Cost ..9 4.5 Evaluation methods 9 4.5.1 General. .9 4.5.2 Testing in the laboratory .9 4.5.3 Testing in user trials .10 4.5.4 Combined approach .10 4.5.5 Interpretation of test results .10 4.5.6 Sample size.. ..11 Bibliography .12 iii icensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 withoutlicense from IHS