ISO INTERNATIONAL STANDARD 22675 Second edition 2016-06-01 Prosthetics Testing of ankle: foot devices and foot units Requirements and test methods Protheses - Essais d'articulations cheville-pied et unités de pied - Exigences et méthodes d'essai Reference number ISO 22675:2016(E) ISO International Organization for Standardization =ZHEJIANG INST OF STANDARDIZATION C1 5956617 @IS02016 vided by IHS under Not for Resale, 2016/7/20 07:50:18 ted without license from IHS IS0 22675:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS02016,PublishedinSwitzerland 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 +41227490947 [email protected] www.iso.org Intenationai br PrganizationforStandardization icensee-ZHEJIANG INST.OF STANDARDIZoISQ s.6 - All rights reserved I by IHS unde Not for Resale, 2016/7/20 07:50:18 etworking permitted without license from IHS IS0 22675:2016(E) Contents Page Foreword ..vi Introduction. ..vi 1 Scope. 2 Normative references 3 Terms and definitions 4 Designations and symbols of test forces. ..2 5 Strength and related performance requirements and conditions of use ..3 6 Coordinate system and test configurations 6.1 General ..4 6.2 Origin and axes of the coordinate system .4 6.3 Reference points .5 6.4 TestforceF ..6 6.5 Line of application of test force F. 6.6 Lines of action of resultant reference forces FR1 and FR2 6.7 Longitudinal axis of the foot and effective ankle joint centre .6 6.7.1 General 6.7.2 Longitudinal axis of the foot. .6 6.7.3 Effective ankle-joint centre, CA. .7 7 Test loading conditions and test loading levels ..8 7.1 Test loading conditions 7.2 Test loading levels ..8 8 Values of test forces, dimensions and cycles ..9 9 Compliance .16 9.1 General ..16 9.2 Particular arrangements and requirements concerning the part required to connect an ankle-foot device or foot unit to the remainder of a prosthetic structure. 9.2.1 Arrangements for testing. .17 9.2.2 Requirements for claiming compliance ..17 9.3 Number of tests and test samples required to claim compliance with this International Standard. ..17 9.4 Multiple use of test samples .18 9.4.1 General. 18 9.4.2 Restriction 18 9.5 Testing at particular test loading levels not specified in this International Standard ..18 10 Test samples .19 10.1 Selection of test samples .19 10.1.1 General .19 10.1.2Selection of ankle-foot devices and foot units of appropriate size of foot .19 10.2 Types of test sample. 20 10.2.1 Complete structure 20 10.2.2 Partial structure 20 10.3 Preparation of test samples. 20 10.4 Identification of test samples 21 10.5 Alignment of test samples .21 10.6 Worst-case alignment position of test samples .21 11 Responsibility for test preparation ..23 12 Test submission document .24 12.1 General requirements .24 12.2 Information required for test samples .24 iii n5ee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 vided by IHS under license with ISt