EN ISO 22675:2016

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)

IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to this International Standard.
WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.
ISO 22675:2016 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, ISO 22675:2016 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.

Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und Prüfverfahren (ISO 22675:2016)

Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et méthodes d'essai (ISO 22675:2016)

IMPORTANT ? ISO 22675:2016 permet d'évaluer la conformité des unités de pied et des ensembles cheville-pied prothétiques aux exigences de résistance spécifiées en 4.4 de l'ISO 22523:2006 (voir NOTE 1). Les unités de pied et les ensembles cheville-pied prothétiques commercialisés, conformes aux exigences concernant la résistance spécifiées en 4.4 de l'ISO 22523:2006 après soumission aux essais appropriés de l'ISO 10328:2006, sont réputés conformes à la présente Norme internationale.
AVERTISSEMENT ? ISO 22675:2016 n'a pas pour objectif de proposer des critères permettant de choisir un ensemble cheville-pied ou une unité de pied spécifique lors de la prescription d'une prothèse de membre inférieur ! La non prise en compte de cet avertissement peut entraîner des risques pour la sécurité des personnes amputées.
ISO 22675:2016 spécifie essentiellement un mode opératoire d'essais cycliques portant sur les ensembles cheville-pied et les unités de pied des prothèses externes pour membres inférieurs. Ce mode opératoire se distingue par la possibilité de modéliser, de manière réaliste, les conditions de mise en contrainte pendant la phase complète d'appui lors de la marche (depuis l'attaque au talon jusqu'au décollement des orteils), qui sont pertinentes pour la vérification des exigences de performances telles que la résistance, la durabilité et la durée de vie de l'appareil.
Cela est particulièrement important dans le cadre de l'évaluation des performances de divers ensembles cheville-pied et unités de pied de conception récente et qui présentent des caractéristiques visibles uniquement dans des conditions de mise en contrainte réalistes.
En outre, ISO 22675:2016 spécifie un mode opératoire d'essai statique portant sur les ensembles cheville-pied et unités de pied prothétiques, qui comprend un essai statique de charge et un essai statique de résistance à la rupture. L'essai se distingue, entre autres (voir NOTE 2), par la possibilité de générer des forces du talon et de l'avant du pied au niveau de lignes d'action comparables à celles développées au moment où s'exercent les contraintes maximales au niveau du talon et de l'avant du pied lors de l'essai cyclique.
Les conditions de mise en contrainte traitées dans le troisième paragraphe se caractérisent par un profil de contrainte, déterminé par le vecteur qui résulte des forces verticales et horizontales (A-P) de réaction du sol, et par un profil de locomotion, déterminé par l'angle du tibia.
Les conditions de mise en contrainte d'essai spécifiées dans la présente Norme internationale se caractérisent par les formats type de ces profils de contrainte et de locomotion, utilisés de manière systématique dans les modes opératoires d'essais cyclique et statique auxquels est soumis chaque échantillon d'ensemble cheville-pied ou d'unité de pied.

Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo - Zahteve in preskusne metode (ISO 22675:2016)

POMEMBNO: ta mednarodni standard je primeren za oceno skladnosti protetičnih pripomočkov za gleženj in stopalo ter enot za stopalo z zahtevami glede trdnosti, določenimi v točki 4.4 standarda ISO 22523:2006 (glej OPOMBA 1). Protetičnih pripomočkov za gleženj in stopalo ter enot za stopalo, ki so na voljo na tržišču in dokazano izpolnjujejo zahteve, podane v točki 4.4 standarda ISO 22523:2006, na podlagi opravljenih ustreznih preskusov v skladu s standardom ISO 10328:2006, ni treba znova preskusiti v skladu s tem mednarodnim standardom.
OPOZORILO: ta mednarodni standard ni primeren za uporabo kot vodilo za izbiro določenega protetičnega pripomočka za gleženj in stopalo ali enote za stopalo pri predpisovanju posamezne proteze za spodnje okončine. Morebitno neupoštevanje tega opozorila lahko pomeni varnostno tveganje za amputirance.
Ta mednarodni standard prvenstveno določa ciklični preskusni postopek za pripomočke za gleženj in stopalo ter enote za stopalo zunanje proteze za spodnje okončine, ki se razlikuje glede na možnost simulacije dejanskih pogojev obremenitve v celotni fazi drže pri hoji vse od obremenitve pete do razbremenitve prstov. Ti pogoji so pomembni za preverjanje zahtev glede zmogljivosti, kot so trdnost, trpežnost in življenjska doba.
Ta možnost je bistvenega pomena za oceno zmogljivosti različnih najnovejših zasnov pripomočkov za gleženj in stopalo ter enot za stopalo s posebnimi značilnostmi, ki se razvijejo samo pri dejanskih pogojih obremenitve.
Poleg tega ta mednarodni standard določa statični preskusni postopek za pripomočke za gleženj in stopalo ter enote za stopalo, sestavljen iz statičnega dokaznega preskusa in statičnega preskusa skrajne trdnosti, ki se med drugim (glej OPOMBA 2) razlikujeta glede na možnost ustvarjanja sil na peto in sprednji del stopala v točkah delovanja, ki ustrezajo silam, ki nastanejo v trenutku največje obremenitve pete in sprednjega dela stopala pri cikličnem preskusu.
Pogoje obremenitve, omenjene v tretjem odstavku, označuje profil obremenitve, določen na podlagi pridobljenega vektorja navpičnih in vodoravnih (A-P) talnih reakcijskih sil, ter profil premikanja, določen na podlagi naklona golena.
Preskusne pogoje obremenitve, opredeljene v tem mednarodnem standardu, označuje standardizirana oblika tega profila obremenitve in profila premikanja za namene enotne uporabe pri cikličnem in statičnem preskusnem postopku za vsak primerek pripomočka za gleženj in stopalo ter enote za stopalo, predložen za preskušanje.
Glede na koncept preskusov v skladu s tem mednarodnim standardom pa lahko posamezen primerek pripomočka za gleženj in stopalo ter enote za stopalo, predložen za preskušanje, pod obremenitvijo razvije lastno učinkovitost uporabe.
OPOMBA 1: točke delovanja sil na peto in sprednji del stopala, ustvarjene pri statičnem preskusnem postopku v skladu s tem mednarodnim standardom, se približajo točkam, ki določajo obremenitev sagitalne ravnine v okviru preskusnih pogojev obremenitve I in II za glavne preskuse strukture, opredeljene v standardu ISO 10328:2016, brez spreminjanja vrednosti naklona pete in sprednjega dela stopala za preskuse strukture pri pripomočkih za gleženj in stopalo ter enotah za stopalo, opredeljenih v standardu ISO 10328:2016.

General Information

• Status: Withdrawn
• Publication Date: 21-Jun-2016
• Withdrawal Date: 22-Sep-2025
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293 - Technical aids for disabled persons
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 21-May-2025
• Completion Date: 23-Sep-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 22675:2016 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)

Relations

• Replaces: EN ISO 22675:2006 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)
• Effective Date: 02-Dec-2015
• Replaced By: EN ISO 22675:2025 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024)
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2016
1DGRPHãþD
SIST EN ISO 22675:2006
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo -
Zahteve in preskusne metode (ISO 22675:2016)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test
methods (ISO 22675:2016)
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und
Prüfverfahren (ISO 22675:2016)
Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et
méthodes d'essai (ISO 22675:2016)
Ta slovenski standard je istoveten z: EN ISO 22675:2016
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 22675
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 22675:2006
English Version
Prosthetics - Testing of ankle-foot devices and foot units -
Requirements and test methods (ISO 22675:2016)
Prothèses - Essais d'articulations cheville-pied et Prothetik - Prüfung von Knöchel-Fuß-Passteilen und
unités de pied - Exigences et méthodes d'essai (ISO Fußeinheiten - Anforderungen und Prüfverfahren (ISO
22675:2016) 22675:2016)
This European Standard was approved by CEN on 12 May 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22675:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 4

European foreword
This document (EN ISO 22675:2016) has been prepared by Technical Committee ISO/TC 168 "
Prosthetics and orthoticsa" in collaboration with Technical Committee CEN/TC 293 “Assistive products
for persons with disability” the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2016, and conflicting national standards
shall be withdrawn at the latest by December 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 22675:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, B, C or D, which is an integral part of
this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 22675:2016 has been approved by CEN as EN ISO 22675:2016 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardization request ‘M/023
concerning the development of European standards related to medical devices’ to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the
risk management process needs to be in compliance with Directive 93/42/EEC as amended by
2007/47/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest
possible level’, ‘minimized’ or ‘removed’, according to the wording of the corresponding essential
requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk has to be in compliance with
Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the
European foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not
addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
With respect to use in
9.1 5 combination with other devices
or equipment.
With respect to any restrictions
on use which shall be indicated
9.1 19 and 20
on the label or in the instructions
for use.
Only covered for mechanical
12.7.1 5, 7, 8, 9, 10, 15, 16 and 17
strength.
Essential requirement 13.1 is not
fully covered here; only the
13.1 5, 19, and 20.4
aspects
of classification are addressed.
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
Only covered for classification of
13.3 b) 20
the use of the device.
Only covered for limitations due
to body mass limit and specific
13.3 k) 20.2
activities undertaken by the
user.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 22675
Second edition
2016-06-01
Prosthetics — Testing of ankle-
foot devices and foot units —
Requirements and test methods
Prothèses — Essais d’articulations cheville-pied et unités de pied —
Exigences et méthodes d’essai
Reference number
ISO 22675:2016(E)
©
ISO 2016
ISO 22675:2016(E)
© 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
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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

ISO 22675:2016(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
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 . 4
6.1 General . 4
6.2 Origin and axes of the coordinate system . 4
6.3 Reference points . 5
6.4 Test force F .6
6.5 Line of application of test force F .6
6.6 Lines of action of resultant reference forces F and F .
R1 R2 6
6.7 Longitudinal axis of the foot and effective ankle joint centre. 6
6.7.1 General. 6
6.7.2 Longitudinal axis of the foot . 6
6.7.3 Effective ankle-joint centre, C .
A 7
7 Test loading conditions and test loading levels . 8
7.1 Test loading conditions . 8
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 .17
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
10.1.2 Selection 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
ISO 22675:2016(E)
12.3 Information required for tests .25
12.3.1 General.25
12.3.2 For all tests .25
12.3.3 For the static proof test and the static ultimate strength test .25
12.3.4 For the static ultimate strength test .25
12.3.5 For the cyclic test .25
13 Equipment .26
13.1 General .26
13.2 End attachments .26
13.2.1 General.26
13.2.2 Proof test of end attachments . .26
13.3 Jig (optional) .28
13.4 Test equipment .29
13.4.1 Test equipment to perform static heel and forefoot loading .29
13.4.2 Test equipment to perform cyclic loading .30
14 Accuracy .37
14.1 General .37
14.2 Accuracy of equipment .37
14.3 Accuracy of procedure .37
15 Test principles .38
15.1 General .38
15.2 Static test procedure .39
15.3 Cyclic test procedure .39
16 Test procedures .39
16.1 Test loading requirements .39
16.1.1 Preparation for test loading .39
16.1.2 Test loading conditions .43
16.2 Static proof test .43
16.2.1 Test method .43
16.2.2 Performance requirement .45
16.2.3 Compliance conditions .45
16.3 Static ultimate strength test .47
16.3.1 Test method .47
16.3.2 Performance requirements .50
16.3.3 Compliance conditions .50
16.4 Cyclic test .51
16.4.1 Test method .51
16.4.2 Performance requirements .54
16.4.3 Compliance conditions .55
17 Test laboratory/facility log .57
17.1 General requirements .57
17.2 Specific requirements .57
18 Test report .57
18.1 General requirements .57
18.2 Specific requirements .58
18.3 Options .58
19 Classification and designation .58
19.1 General .58
19.2 Examples of classification and designation .58
20 Labelling .59
20.1 General .59
20.2 Use of mark “*)” and warning symbol .60
20.3 Examples of label layout .60
20.4 Label placement .61
iv © ISO 2016 – All rights reserved

ISO 22675:2016(E)
Annex A (informative) Reference data for the specification of the test loading conditions
and test loading levels of this International Standard .62
Annex B (informative) Guidance on the application of an alternative static ultimate
strength test .70
Annex C (normative) Application of an additional test loading level P6, P7, and P8 .71
Annex D (informative) Summary of the records to be entered in the test laboratory/facility log .73
[[1]]
Annex E (informative) Information on Technical Report ISO/TR 22676 .79
Annex F (informative) Reference to the essential principles of safety and performance of
medical devices according to ISO/TR 16142 .90
Bibliography .91
ISO 22675:2016(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 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 (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 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 identifying 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 convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 168, Prosthetics and orthotics.
This second edition cancels and replaces the first edition ISO 22675:2006 which has been technically
revised with the following changes:
a) Test loading levels P7 and P8 have been introduced in Table 10, Table A.1, Table C.1, Table C.2 and
the clauses pointing at these tables have been updated. Additional information on P7 and P8 is
given in Annex A.1;
b) Table 9 has been revised
c) Annex C has changed from informative to normative
vi © ISO 2016 – All rights reserved

ISO 22675:2016(E)
Introduction
This International Standard offers alternatives to the structural tests on ankle-foot devices and foot
units specified in 17.2 of ISO 10328:2016, which still suffer from several “weaknesses”, such as:
a) the inconsistency of the lines of application of the heel and forefoot test forces with those of the test
forces of test loading conditions I and II for the principal structural tests specified in 16.2 (static
tests) and 16.3 (cyclic test) of ISO 10328:2016;
b) the unrealistic course and magnitude of loading in the phase between the instants of maximum
heel and forefoot loading during the cyclic test;
c) the effect of periodical “stepping in a hollow” during the cyclic test, resulting from simultaneous
heel and forefoot loading at different angles.
In this relation it is important to note that the complexity of the test equipment required for the
testing of ankle-foot devices and foot units specified in this International Standard is low, comparable
to that of the test equipment required for the corresponding separate structural tests specified in
ISO 10328:2016. Apparently, basic components of both types of test equipment are similar and can be
re-used in a modified design.
Finally, it has to be noted that the potential of the general concept applied to the test procedures
specified in this International Standard allows other applications directed to the assessment of specific
performance characteristics of ankle-foot devices and foot units that may be of relevance in the future.
NOTE Further guidance on the specification of the test loading conditions and test loading levels and on
the design of appropriate test equipment is given in a separate document, published as a Technical Report (see
Bibliography).
INTERNATIONAL STANDARD ISO 22675:2016(E)
Prosthetics — Testing of ankle-foot devices and foot units
— Requirements and test methods
1 Scope
IMPORTANT — This International Standard is suitable for the assessment of the conformity of
prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4
of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market,
which have demonstrated their compliance with the strength requirements specified in 4.4
of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be
retested to this International Standard.
WARNING — This International Standard is not suitable to serve as a guide for the selection of a
specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis!
Any disregard of this warning can result in a safety risk for amputees.
This International Standard primarily specifies a cyclic test procedure for ankle-foot devices and foot
units of external lower limb prostheses, distinguished by the potential to realistically simulate those
loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant
to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent
designs of ankle-foot devices and foot units with specific characteristics that will only develop under
realistic conditions of loading.
In addition, this International Standard specifies a static test procedure for prosthetic ankle-foot
devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished,
besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of
action conforming to those occurring at the instants of maximum heel and forefoot loading during the
cyclic test.
The loading conditions addressed in the third paragraph are characterized by a loading profile
determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a
locomotion profile determined by the tibia angle.
The test loading conditions specified in this International Standard are characterized by standardized
formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test
procedures to each sample of ankle-foot device or foot unit submitted for test.
According to the concept of the tests of this International Standard, each sample of ankle-foot device or
foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
NOTE 1 The lines of action of the heel and forefoot forces generated by the static test procedure specified in
this International Standard approach those determining the sagittal plane loading of the test loading conditions
I and II for the principal structural tests specified in ISO 10328:2016, without changing the values of the angles
of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in
ISO 10328:2016.
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, the latest edition of the referenced document (including any amendments) applies.
ISO 22675:2016(E)
ISO 8549-1:1989, Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb
prostheses and external orthoses
ISO 10328:2016, Prosthetics — Structural testing of lower limb prostheses — Requirements and test methods
ISO 22523:2006, External limb prostheses and external orthoses — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8549-1:1989 and the
following apply.
3.1
proof strength
static load representing an occasional severe event, which can be sustained by the ankle-foot device or
foot unit and still allow it to function as intended
3.2
ultimate strength
static load representing a gross single event, which can be sustained by the ankle-foot device or foot
unit but which could render it thereafter unusable
3.3
fatigue strength
cyclic load that can be sustained by the ankle-foot device or foot unit for a given number of cycles
3.4
batch
set of test samples of an ankle-foot device or foot unit submitted together to a test laboratory/facility
to undertake tests to demonstrate compliance with one or more requirements of this International
Standard
4 Designations and symbols of test forces
The designations and symbols of all relevant test forces are listed in Table 1.
Table 1 — Designations and symbols of test forces
Designation Symbol
Test forces F, F , F
1 2
Settling test force F
set
Stabilizing test force F
stab
Proof test force of end attachments F
pa
Static proof test force on heel/forefoot F , F
1sp 2sp
Static ultimate test force on heel/forefoot F , F
1su 2su
Pulsating test force F (t); F (γ)
c c
1st and 2nd maximum value of pulsating test force F , F
1cmax 2cmax
Intermediate minimum value of pulsating test force F
cmin
Final static test force on heel/forefoot F , F
1fin 2fin
NOTE Further details of the test forces listed are given in Table 3.
2 © ISO 2016 – All rights reserved

ISO 22675:2016(E)
5 Strength and related performance requirements and conditions of use
5.1 According to 4.4.1 of ISO 22523:2006, a prosthetic ankle-foot device or foot unit “… shall have
the strength to sustain the loads occurring during use by amputees […] in the manner intended by the
manufacturer for that device according to his written instructions on its intended use”.
For the assessment of the conformity of ankle-foot devices and foot units with the above requirement
(see also Scope), this International Standard provides means of determining different categories of
strength. These are defined in 3.1 to 3.3 and listed in Table 2, together with the related performance
requirements and the test methods for their verification.
5.2 In order to satisfy the general requirement in 5.1 for a specific ankle-foot device or foot unit, the
following safety concept shall apply:
The device shall
a) comply with the requirements of this International Standard (see 9.1 and 9.2) for a specific test
loading level (see 7.2)
and
b) be used in accordance with the body mass limit specified by the manufacturer in consideration of
the intended use of that device (see NOTE).
The conditions in a) and b) are regarded in both the classification and designation of ankle-foot devices
and foot units according to Clause 19 and their labelling according to Clause 20.
NOTE The statement of the body mass limit not to be exceeded by amputees is part of the conditions of use to
be specified, with justification, by the manufacturer in his written instructions on the intended use of a specific
ankle-foot device or foot unit, taking account of all other factors affecting the loads expected to be exerted on
that ankle-foot device or foot unit by amputees (see Clause A.1).
Table 2 — Categories of strength addressed in this International Standard,
together with the related performance requirements and test methods for their verification
a
Category of strength Related performance requirement Test method for verification
Structure shall sustain static loading by the
Static proof test (16.2.1), successively
Proof strength (see 3.1) proof test forces F and F at the prescribed
1sp 2sp
applying heel and forefoot loading.
values for the prescribed time (see 16.2.2).
Structure shall sustain static loading by the Static ultimate strength test (16.3.1),
Ultimate strength (see 3.2) ultimate test forces F and F at the pre- separately applying heel and forefoot
1su 2su
scribed values (see 16.3.2). loading.
Structure shall sustain successively (see 16.4.2)
Cyclic test procedure (16.4.1),
1) cyclic loading by the pulsating test force
F (t) or F (γ) at the prescribed profile for the
c c
repeatedly applying a loading profile
Fatigue strength (see 3.3) prescribed number of cycles and
simulating the stance phase of walk-
ing, followed by final static heel and
2) final static loading by the final test
forefoot loading.
forces F and F at the prescribed values
1fin 2fin
for the prescribed time.
a
The performance requirements related to a specific category of strength are specified in full in an individual subclause
following the subclause in which the test method for their verification is specified.
ISO 22675:2016(E)
6 Coordinate system and test configurations
6.1 General
The test configurations of this International Standard are defined in a manner similar to that applied in
ISO 10328:2016.
Each test configuration shall be defined in a two-dimensional, rectangular coordinate system (see
Figure 1).
Each test configuration specifies reference parameters both for the position of the line of application of
the test force and for the alignment of test samples within the coordinate system.
6.2 Origin and axes of the coordinate system
The origin and the axes of the coordinate system are specified in a) to c) in relation to a prosthes
...