BS PD ISO TS 16955-2016 Prosthetics Quantification of physical parameters of ankle foot devices and foot units《假肢 踝足器械和足装置的物理参数量化》.pdf

1、Prosthetics Quantification of physical parameters of ankle foot devices and foot units PD ISO/TS 16955:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword T h i s P u b l i s h e d D o c u m e n t i s t h e U K i m p l e m e n t a t i o n o f I S

2、O / T S 1 6 9 5 5 : 2 0 1 6 . The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics and orthotics. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necess

3、ary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 92002 8 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Docum

4、ent was published under the authority of the Standards Policy and Strategy Committee on 30 June 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 16955:2016 ISO 2016 Prosthetics Quantification of physical parameters of ankle foot devices and foot un

5、its Prothses Quantification des paramtres physiques des dispositifs de cheville/pied et units pour les pieds TECHNICAL SPECIFICATION ISO/TS 16955 Reference number ISO/TS 16955:2016(E) First edition 2016-06-15 PD ISO/TS 16955:2016 ISO/TS 16955:2016(E)ii ISO 2016 All rights reserved COPYRIGHT PROTECTE

6、D DOCUMENT ISO 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 w

7、ritten permission. Permission can be requested from either ISO at the address below or ISOs 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 copyrightiso.org www.iso.org PD ISO

8、/TS 16955:2016 ISO/TS 16955:2016(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 Terms and definitions . 1 4 Symbols and abbreviated terms . 2 5 Requirements 2 6 Setup conditions . 2 7 Quantification 3 7.1 Heel, mid-foot and toe characteristics 3 7.1.1 Procedure . 3 7.1.2 Data co

9、llection and calculations . 4 7.2 Roll-over characteristics . 5 7.2.1 Procedure . 5 7.2.2 Data collection and calculations . 6 7.3 Torsional characteristic . 7 7.3.1 Procedure . 7 7.3.2 Data collection and calculations . 8 7.4 Frontal plane characteristics 8 7.4.1 Procedure . 8 7.4.2 Data collection

10、 and calculations . 9 8 Accessories 10 8.1 General 10 8.2 Procedure .10 8.3 Results .10 Annex A (informative) Quick reference 11 Annex B (informative) Three dimensional locus of force contact point on foot-sole .12 Bibliography .17 ISO 2016 All rights reserved iii Contents Page PD ISO/TS 16955:2016

11、ISO/TS 16955:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a

12、subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission

13、 (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should

14、 be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for iden

15、tifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the conven

16、ience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformit y assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see

17、the following URL: www.iso.org/iso/foreword.html. The committee responsible for this document is ISO/TC 168 Prosthetics and orthotics.iv ISO 2016 All rights reserved PD ISO/TS 16955:2016 ISO/TS 16955:2016(E) Introduction Three major factors contribute to foot design: a) shape and size; b) strength r

18、equirements; c) functional performance. Where a) is obvious and defined by the footwear, b) is specified in ISO 22523 referring to ISO 22675 (but is not suitable for use as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthes

19、is), and c) is addressed in this Technical Specification. The AOPA group of ISO/TC 168 members between 2006 and 2009 carried out work on a method to replace design criteria for prosthetic ankle-foot devices with compliance criteria which would be applicable to both jointed devices and unjointed devi

20、ces with elastic elements. In 2010, the working group “Testing” convened in Seattle, Washington and decided to work on a standard, based on the work of the AOPA group and other international groups. The vision statement was: “To develop a standard which describes quantitative methods to evaluate or

21、assess key performance indicators of prosthetic ankle-foot devices which are correlated to measurable prosthesis user benefit.” The subsequent work on this task has made it clear that it consists of (at least) two elements: firstly, to develop a standard which describes quantitative methods to evalu

22、ate or assess key performance indicators and secondly, to investigate and attempt to establish the correlation between these measures and relevant measures of prosthetic user benefit. This Technical Specification describes solely the quantitative methods to evaluate or assess key performance indicat

23、ors. The following definitions apply in understanding how to implement an ISO International Standard and other normative ISO deliverables (TS, PAS, IWA). “shall” indicates a requirement “should” indicates a recommendation “may” is used to indicate that something is permitted “can” is used to indicat

24、e that something is possible, for example, that an organization or individual is able to do something In 3.3.1 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a requirement as an “expression in the content of a document conveying criteria to be fulfilled if compliance with the docume

25、nt is to be claimed and from which no deviation is permitted.” In 3.3.2 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a recommendation as an “expression in the content of a document conveying that among several possibilities one is recommended as particularly suitable, without ment

26、ioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action is deprecated but not prohibited.” ISO 2016 All rights reserved v PD ISO/TS 16955:2016 Prosthetics Quantification of phys

27、ical parameters of ankle foot devices and foot units 1 Scope This Technical Specification describes quantitative methods to evaluate or assess key performance indicators of prosthetic ankle foot devices. For each method, the set-up and test configurations are described. Also included is a variety of

28、 parameters which are derived or calculated from the recorded data. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references

29、, the latest edition of the referenced document (including any amendments) applies. ISO 10328, Prosthetics Structural testing of lower-limb prostheses Requirements and test methods ISO 22523:2006, External limb prostheses and external orthoses Requirements and test methods ISO 22675:2016, Prosthetic

30、s Testing of ankle-foot devices and foot units Requirements and test methods 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 heel, mid-foot and toe characteristics physical parameters to describe the response of the ankle foot device under lo

31、ad after heel strike in mid stance and prior toe off 3.2 roll-over characteristics physical parameters to describe the sagittal plane properties of the ankle foot device relevant for the patient during stance-phase 3.3 full contact motion physical parameter to describe the angular range of motion of

32、 the shin where the heel and the toe are in contact with the ground simultaneously 3.4 torsional characteristic physical parameter to describe the rotational response of the ankle foot device under load and additional torque in transversal plane 3.5 frontal plane characteristics physical parameter t

33、o describe the frontal plane response of the ankle foot device during roll over on four different tilted ground angles in frontal plane TECHNICAL SPECIFICATION ISO/TS 16955:2016(E) ISO 2016 All rights reserved 1 PD ISO/TS 16955:2016 ISO/TS 16955:2016(E) 4 Symbols and abbreviated terms Symbols and ab

34、breviated terms are those used in ISO 10328 and ISO 22675. 5 Requirements To determine comprehensive ankle foot device performance and to claim compliance with this Technical Specification, all parameters shall be quantified and the strength requirements specified in ISO 22523:2006, 4.4, shall be me

35、t. If an ankle foot device allows for different adjustments on key performance indicators, the manufacturer/submitter shall define the settings relevant for quantification. To claim compliance with this Technical Specification, all parameters shall be quantified in the specific adjustments and the s

36、trength requirements specified in ISO 22523:2006, 4.4, shall be met. Samples for the quantification shall be from the same production batch as those for strength testing. If not otherwise specified in this Technical Specification, the test preparation as described in ISO 10328 or ISO 22675 shall app

37、ly. NOTE The order of tests given in Table A.1 minimizes the effort for test setup and configuration. 6 Setup conditions Use the coordinate system and test configurations specified in ISO 22675:2016, Clause 6, except P Tis located at 700 mm height on a line which is located at midfoot and parallel t

38、o the u-axis. The test methods specified are defined for a prosthetic foot of size 26 cm and appropriate for a 70 kg amputee. For all the described test methods, a force moment sensor shall be positioned above midfoot and at the height of 500 mm, see Figure 1. In order to quantify the influence of c

39、ompliant components between knee and ankle foot device, the force moment sensor is positioned at a height of 500 mm. A displacement sensor rigidly connected to the force moment sensor parallel to u-axis shall be used to record vertical displacement (s u ). An angular sensor rigidly connected to the

40、force moment sensor perpendicular to u-axis shall be used to record the torsional angle ( u ). Using the data acquired by the sensors, the following characteristics shall be calculated. Stiffness at static plate angle D l= (F u / s u ) Lever arm length at static plate angle l = (M o /F u ) NOTE Calc

41、ulations in ranges of F u 10 % F umaxto be considered carefully because of noise. Lever arm length changes at static plate angle l s= l 2 -l 1 Effective foot length at tilting plate l lt= l 2 -l 1 Full contact motion at tilting plate = 2 - 12 ISO 2016 All rights reserved PD ISO/TS 16955:2016 ISO/TS

42、16955:2016(E) Energy at static plate angle E = F u s u Torsional stiffness D = (M u / u ). Torsional angular range u= u2 - u1 Effective foot width at tilting plate l wt= l 2 -l 1 Figure 1 Setup 7 Quantification 7.1 Heel, mid-foot and toe characteristics 7.1.1 Procedure Perform the quantification of

43、the heel, mid-foot and toe characteristics using the geometrical configuration of foot and foot platform described for loading in ISO 22675:2016, 13.4.1.3, using plate angles of -7,5 and 10 in addition (see Figure 2). The peak force in the loading profile for quantification of the heel and toe chara

44、cteristics (see Figure 3) shall be in accordance with 120 % (824 N) of the maximum body weight for which the ankle foot device is designed The loading and unloading time shall be within (1 0,1) s. Perform the quantification of mid-foot characteristic as stated above but with the foot plate horizonta

45、l (0) and the peak force in the loading profile (see Figure 3) in accordance with 200 % (1 373 N) of the maximum body weight for which the ankle foot device is designed. The loading and unloading time shall be within (1 0,1) s. ISO 2016 All rights reserved 3 PD ISO/TS 16955:2016 ISO/TS 16955:2016(E)

46、 Figure 2 Heel, mid-foot and toe characteristics (tilting angle of foot platform) The loading profile shall be a sinusoidal wave with the peak at the specified load. Figure 3 Loading profile 7.1.2 Data collection and calculations During the test, vertical displacement (s u ), vertical force (F u ) a

47、nd outward moment (M o ) shall be recorded. Using this data the following characteristics shall be calculated (see also Table 1).4 ISO 2016 All rights reserved PD ISO/TS 16955:2016 ISO/TS 16955:2016(E) Table 1 Heel, mid-foot and toe characteristics Test Parameter Measured signal/Calculated value Hee

48、l and toe 1) Stiffness 2) Lever arm length at F u max 3) Lever arm length changes 4) Moment 5) Energy Mid-foot 1) Stiffness 2) Lever arm length at F umax 3) Energy 7.2 Roll-over characteristics 7.2.1 Procedure Perform the quantification of the roll-over characteristics (see Figure 4) using the geome

49、trical configuration of foot and foot platform and the loading profile described in ISO 22675:2016, 13.4.2, except applying the force of F 1cmaxbetween the plate angles 15 and +20 (see Figure 5), and the duration of the loading profile shall be within 600 ms 10 %. ISO 2016 All rights reserved 5 PD ISO/TS 16955:2016 ISO/TS 16955:2016(E) Figure 4 Roll-over characteristics Figure 5 Loading profile and foot platform angle 7.2.2 Data coll