SIST EN ISO 22675:2025

SLOVENSKI STANDARD
01-julij-2025
Nadomešča:
SIST EN ISO 22675:2016
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo -
Zahteve in preskusne metode (ISO 22675:2024)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test
methods (ISO 22675:2024)
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und
Prüfverfahren (ISO 22675:2024)
Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et
méthodes d'essai (ISO 22675:2024)
Ta slovenski standard je istoveten z: EN ISO 22675:2025
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
May 2025
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 22675:2016
English Version
Prosthetics - Testing of ankle-foot devices and foot units -
Requirements and test methods (ISO 22675:2024)
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
22675:2024) 22675:2024)
This European Standard was approved by CEN on 19 November 2024.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22675:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
This document (EN ISO 22675:2025) has been prepared by Technical Committee ISO/TC 168
"Prosthetics and orthotics" in collaboration with Technical Committee CEN/TC 293 “Assistive products
and accessibility” 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 November 2025, and conflicting national standards
shall be withdrawn at the latest by November 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 22675:2016.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 22675:2024 has been approved by CEN as EN ISO 22675:2025 without any modification.

Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
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 General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance 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 Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical investigations,
clinical evaluation or post-market clinical follow-up
General Safety and Clause(s) / sub-clause(s) Remarks/Notes
Performance Requirements of
of this EN
Regulation (EU) 2017/745
Covered with respect to
mechanical strength of the ankle-
foot device or foot unit in
combination with the remainder of
a prosthetic structure. Risks
arising from misconnections are
14.1 5, 9, 19 and 20
not covered.
Covered with respect to any
restrictions on use which shall be
indicated on the identifier or in the
instructions for use.
Only covered for mechanical
20.1 5, 7, 8, 9, 10, 15, 16 and 17
strength.
General Safety and Performance
Requirement 23.1 is not fully
23.1 19 and 20.3
covered here; only the aspects of
classification are addressed.
Only covered for classification of
23.2 b) 19 and 20
the use of the device.
Only covered for limitations due to
23.2 m) 7, 19 and 20.1 body mass limit and specific
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.
Table ZA.2 — Normative references from Clause 2 of this document and their corresponding
European publications
Column 4
Column 2
Column 1 Column 3
Corresponding
International
Reference in Clause 2 Title European Standard
Standard Edition
Edition
ISO 7000 ISO 7000:2019 Graphical symbols for None
use on equipment —
For applicable standard
Registered symbols
edition see Column 2
ISO 8549-1 ISO 8549-1:2020 Prosthetics and None
orthotics —
For applicable standard
Vocabulary — Part 1:
edition see Column 2
General terms for
external limb
prostheses and external
orthoses
ISO 10328:2016 ISO 10328:2016 Prosthetics — EN ISO 10328:2016
Structural testing of
lower-limb prostheses
— Requirements and
test methods
ISO 22523:2006 ISO 22523:2006 External limb EN ISO 22523:2006
prostheses and external
orthoses —
Requirements and test
methods
IEC 60417 IEC 60417:2002 DB Graphical symbols for None
use on equipment
For applicable standard
edition see Column 2
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
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
Standard
ISO 22675
Third edition
Prosthetics — Testing of ankle-
2024-12
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 22675:2024(en) © ISO 2024
ISO 22675:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 22675:2024(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols . 3
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 .6
R1 R2
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 .6
A
7 Test loading conditions and test loading levels . 8
7.1 Test loading conditions .8
7.2 Test loading levels and Test Ranges (R) .8
8 Values of test forces, dimensions and cycles . 9
9 Compliance . 17
9.1 General .17
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 .18
9.2.1 Arrangements for testing .18
9.2.2 Requirements for claiming compliance .18
9.3 Number of tests and test samples required to claim compliance with this document .18
9.4 Multiple use of test samples . .18
9.4.1 General .18
9.4.2 Restriction .19
9.5 Testing at particular test loading levels not specified in this document .19
10 Test samples .20
10.1 Selection of test samples . 20
10.1.1 General . 20
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot . 20
10.2 Types of test sample . .21
10.2.1 Complete structure .21
10.2.2 Partial structure .21
10.3 Preparation of test samples .21
10.4 Identification of test samples .21
10.5 Alignment of test samples . 22
10.6 Worst-case alignment position of test samples . 22
11 Responsibility for test preparation .24
12 Test submission document . .25
12.1 General requirements . 25
12.2 Information required for test samples . 25
12.3 Information required for tests . 26
12.3.1 General . 26

iii
ISO 22675:2024(en)
12.3.2 For all tests . 26
12.3.3 For the static proof test and the static ultimate strength test . 26
12.3.4 For the static ultimate strength test . 26
12.3.5 For the cyclic test . 26
13 Equipment .27
13.1 General .27
13.2 End attachments .27
13.2.1 General .27
13.2.2 Proof test of end attachments.27
13.3 Jig . 29
13.4 Test equipment . 30
13.4.1 Test equipment to perform static heel and forefoot loading . 30
13.4.2 Test equipment to perform cyclic loading .31
14 Accuracy .37
14.1 General .37
14.2 Accuracy of equipment . 38
14.3 Accuracy of procedure . 38
15 Test principles .38
15.1 General . 38
15.2 Static test procedure . 39
15.3 Cyclic test procedure .42
16 Test procedures .42
16.1 Test loading requirements .42
16.1.1 Preparation for test loading .42
16.1.2 Test loading conditions .45
16.2 Static proof test . 46
16.2.1 Test method . 46
16.2.2 Performance requirement . 48
16.2.3 Compliance conditions . 48
16.3 Static ultimate strength test . 50
16.3.1 Test method . 50
16.3.2 Performance requirements .52
16.3.3 Compliance conditions .52
16.4 Cyclic test . 53
16.4.1 Test method . 53
16.4.2 Performance requirements . . 56
16.4.3 Compliance conditions . 56
16.5 Separate static test in torsion .59
16.5.1 General .59
16.5.2 Purpose of test .59
16.5.3 Test method .59
16.5.4 Performance requirements . . 60
16.5.5 Compliance conditions . 60
17 Test laboratory/facility log . 61
17.1 General requirements .61
17.2 Specific requirements .61
18 Test report . 61
18.1 General requirements .61
18.2 Specific requirements .62
18.3 Options.62
19 Classification and designation .62
19.1 General .62
19.2 Example of classification and designation .62
20 Identifier . .63
20.1 General . 63

iv
ISO 22675:2024(en)
20.2 Identifier layout . 63
20.3 Identifier placement . 63
Annex A (informative) Reference data for the specification of the test loading conditions and
test loading levels of this document .64
Annex B (informative) Guidance on the application of an alternative static ultimate strength
test .73
Annex C (informative) Summary of the records entered in the test laboratory/facility log . 74
Annex D (informative) Information on ISO/TR 22676 .79
Annex E (informative) Background data (reduced) of the six-minute walk test for adults .90
Bibliography .91

v
ISO 22675:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive
products and accessibility, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 22675:2016), which has been technically
revised.
The main changes are as follows:
— test Ranges (R) have been introduced;
— test loading levels P7 and P8 have been introduced in Table 5, 8, 9, 10, 11 and A.1 and the clauses pointing
at these tables have been updated;
— Former Annex C has been deleted and integrated in main text;
— Subclause 15.2 has been updated;
— Subclause 16.5 has been added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

vi
ISO 22675:2024(en)
Introduction
This document offers alternatives to the structural tests on ankle-foot devices and foot units specified in
ISO 10328:2016, 17.2, 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 document 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, the potential of the general concept applied to the test procedures specified in this document allows
other applications directed to the assessment of specific performance characteristics of ankle-foot devices
and foot units that can 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 ISO/TR 22676.

vii
International Standard ISO 22675:2024(en)
Prosthetics — Testing of ankle-foot devices and foot units —
Requirements and test methods
WARNING — This document 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.
1 Scope
This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external
lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of
the complete stance phase of walking from heel strike to toe-off which is 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 document 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), 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.
These loading conditions 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 document are characterized by standardized formats of these
loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot
device or foot unit submitted for test.
This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to
the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or
foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with
the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). 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 10328:2016, need not be
retested to this document.
NOTE The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4
(R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I
and II for the principal structural tests referring to 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 are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest
...