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
Published
Publication Date
21-Jun-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
22-Jun-2016
Completion Date
22-Jun-2016

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SLOVENSKI STANDARD
SIST EN ISO 22675:2016
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
SIST EN ISO 22675:2016 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 22675:2016
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SIST EN ISO 22675:2016
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.
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SIST EN ISO 22675:2016
EN ISO 22675:2016 (E)
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

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SIST EN ISO 22675:2016
EN ISO 22675:2016 (E)
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.

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SIST EN ISO 22675:2016
EN ISO 22675:2016 (E)
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.
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SIST EN ISO 22675:2016
EN ISO 22675:2016 (E)
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.
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SIST EN ISO 22675:2016
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SIST EN ISO 22675:2016
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
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SIST EN ISO 22675:2016
ISO 22675:2016(E)
COPYRIGHT PROTECTED 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

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 +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 22675:2016
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 2016 – All rights reserved iii
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SIST EN ISO 22675:2016
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
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SIST EN ISO 22675:2016
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 (i
...

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