ISO INTERNATIONAL STANDARD 10328 Secondedition 2016-06-01 Prosthetics Structural testing of lower-limb prostheses Requirements and test methods Protheses - Essais portant sur la structure des protheses de membres inférieurs - Exigences et méthodes d'essai Reference number IS0 10328:2016(E) ISO International Organization for Standardization see=ZHEJIANG INST OF STANDARDIZATION C1 5956617 @IS02016 No reproduction or networking permitted without license from IHS IS0 10328:2016(E) COPYRIGHT PROTECTED DOCUMENT 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 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 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 Internationai ibr DrganizationforStandardization icensee-ZHEJIANG INSTOF STANDARDIZAoISQ 06 - All rights reserved networking permited withoutlicense from IHS IS0 10328:2016(E) Contents Page Foreword ..vi Introduction. ..viii 1 Scope. 2 Normative references .... 3 Terms and definitions 4 Designations and symbols of test forces and moments .2 5 Strength and related performance requirements and conditions of use 3 6 Coordinate systems and test configurations :5 6.1 General :5 6.2 Axes of coordinate systems 1.5 6.3 Reference planes 5 6.3.1 General. .5 6.3.2 Top reference plane, T 5 .5 6.3.3 Knee reference plane, K 6.3.4 Ankle reference plane, A .6 6.3.5 Bottom reference plane, B .6 6.4 Reference points. 7 6.5 Testforce. .8 6.6 Load line .8 6.7 Longitudinal axis of the foot and effective joint centres and centrelines 8 6.7.1 General. .8 6.7.2 Longitudinal axis of the foot. ..8 6.7.3 Effective ankle-joint centre.. 6.7.4 Effective ankle-joint centreline ..10 6.7.5 Effective knee-joint centreline. 6.7.6 Effective knee-joint centre. .11 6.8 Reference distances ..11 6.8.1 Offsets. ..11 6.8.2 Combined offsets. ..11 6.8.3 Effective lever arms LA and Lk ..11 6.8.4 Distance LBT . 11 7 Test loading conditions and test loading levels ..11 7.1 Test ioading conditions. ..11 7.1.1 General. .11 7.1.2 Test loading conditions of principal structural tests ..12 7.1.3 Test loading conditions of separate structural tests .12 7.2 Test loading levels.. ..12 8 Values of test loads, dimensions and cycles ..13 9 Compliance ..20 9.1 General 20 9.2 Selection of tests required to claim compliance with this International Standard 9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices or foot units, required to claim compliance with this International Standard 9.3.1 General. .21 9.3.2 Particular arrangements concerning the ankle-foot device or foot unit. ..21 9.3.3 Particular arrangements and requirements concerning the part required to connect the ankle-foot device or foot unit to the remainder of the prosthetic structure. ..21 9.4 Number of tests and test samples required to claim compliance with this International Standard. ..22 9.5 Multiple use of test samples. ..22 Inteainal oganzation @s1S@r216 - All rights reserved iii icensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ed without license from IHS Not for Resale, 2016/7/20 07:45:02 IS0 10328:2016(E) 9.5.1 General. 22 9.5.2 Restriction 22 9.6 Testing at particular test loading levels not specified in this International Standard 23 10 Test samples .25 10.1 Selection of test samples 25 10.1.1 General. 25 10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot 26 10.2 Typesoftestsamples 27 10.2.1 Complete structure. .27 10.2.2 Partial structure. 29 10.2.3 Any other structure 29 10.3 Preparation of test samples. 29 10.4 Identification of test samples 30 10.5 Alignmentoftestsamples 31 10.5.1Test samples for principal tests and separate tests on knee locks .31 10.5.2 Test samples for separat