SIST EN ISO 22675:2025
(Main)Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024)
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.
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und Prüfverfahren (ISO 22675:2024)
Dieses Dokument legt in erster Linie ein dynamisches Prüfverfahren für Knöchel-Fuß-Passteile und Fußeinheiten von externen Prothesen der unteren Gliedmaßen fest, die sich durch die Möglichkeit unterscheiden, die Belastungsbedingungen der gesamten Standphase des Laufvorgangs vom Fersenauftritt bis zum Zehenabheben wirklichkeitsnah zu simulieren, was für die Verifizierung von Leistungsanforderungen, wie z. B. Festigkeit, Dauerhaftigkeit und Lebensdauer, entscheidend ist.
Dieses Potential ist von besonderer Bedeutung für die Bewertung der Gebrauchstauglichkeit einer Vielzahl an neuen Konstruktionen von Knöchel-Fuß-Passteilen und Fußeinheiten mit bestimmten Merkmalen, die nur unter wirklichkeitsnahen Belastungsbedingungen zutage treten.
Außerdem ist in diesem Dokument ein statisches Prüfverfahren für prothetische Knöchel-Fuß-Passteile und Fußeinheiten festgelegt, das aus einer Prüfung der statischen Mindestfestigkeit und einer Prüfung der statischen Grenzfestigkeit besteht und sich neben anderen Merkmalen (siehe Anmerkung) durch die Möglichkeit unterscheidet, auf Ferse und Vorfuß Prüfkräfte an Wirkungslinien aufzubringen, die denen entsprechen, die während der dynamischen Prüfung zu den Zeitpunkten der Höchstbelastung von Ferse und Vorfuß auftreten.
Diese Belastungsbedingungen werden durch ein Belastungsprofil beschrieben, das durch den resultierenden Vektor der vertikalen und horizontalen (A-P) Bodenreaktionskräfte bestimmt wird, und durch ein Fortbewegungsprofil, das durch den Winkel des Schienbeins bestimmt wird.
Die in diesem Dokument festgelegten Prüfbelastungsbedingungen sind durch genormte Formen dieser Belastungs- und Fortbewegungsprofile gekennzeichnet, die nach den dynamischen und statischen Prüfverfahren einheitlich auf jeder zu prüfenden Probe der Knöchel-Fuß-Passteile oder Fußeinheit angewendet werden.
Dieses Dokument legt Prüfbereiche (R) fest, indem es das Fortbewegungsprofil für die zyklische Prüfung in Bezug auf den vorgesehenen Gebrauch spezifiziert. Nach dem Konzept der Prüfungen dieses Dokuments ist jede Probe von Knöchel-Fuß-Passteilen oder Fußeinheiten, die zur Prüfung vorgelegt wird, dennoch uneingeschränkt in der Lage, ihre individuelle Leistungsfähigkeit unter Belastung zu entfalten.
Dieses Dokument ist geeignet für die Bewertung und Prüfung von prothetischen Knöchel-Fuß-Passteilen und Fußeinheiten nach den in ISO 22523:2006, 4.4, festgelegten Anforderungen zur Festigkeit (siehe ANMERKUNG). Auf dem Markt erhältliche Knöchel-Fuß-Passteile und Fußeinheiten, deren Übereinstimmung mit den in ISO 22523:2006, 4.4, festgelegten Anforderungen an die Festigkeit nachgewiesen wurde, indem sie den entsprechenden Prüfungen von ISO 10328:2016 unterzogen wurden, brauchen nicht erneut nach diesem Dokument geprüft zu werden.
ANMERKUNG Die Wirkungslinien der auf Ferse und Vorfuß aufgebrachten Prüfkräfte des in diesem Dokument festgelegten statischen Prüfverfahrens kommen den Wirkungslinien nah, die die Belastung in der Sagittalebene bei den Prüfbelastungsbedingungen I und II der in ISO 10328:2016 festgelegten Hauptprüfungen der Struktur bestimmen, ohne dass die in ISO 10328:2016 festgelegten Winkel der Plattform(en) für Ferse und Vorfuß bei Prüfungen der Struktur an Knöchel-Fuß-Passteilen und Fußeinheiten geändert werden müssen.
WARNUNG — Dieses Dokument ist nicht dazu geeignet, als Anleitung für die Auswahl eines bestimmten Knöchel-Fuß-Passteils oder einer Fußeinheit bei der Verordnung einer individuellen Prothese der unteren Gliedmaßen zu dienen! Jede Missachtung dieser Warnung kann zu einem Sicherheitsrisiko für Amputierte führen.
Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et méthodes d'essai (ISO 22675:2024)
Le présent document 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, lesquels diffèrent par la possibilité de modéliser, de manière réaliste, les conditions de mise en charge pendant la phase complète d'appui lors de la marche (depuis l'attaque au talon jusqu'au décollement des orteils), qui est pertinente 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 charge réalistes.
En outre, le présent document 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), par la possibilité de générer, au niveau des lignes de charges, des forces au talon et à l'avant-pied comparables à celles développées aux instants où les efforts appliqués au talon et à l'avant-pied lors de l'essai cyclique sont maximaux.
Ces conditions de mise en charge se caractérisent par un profil de chargement déterminé par le vecteur qui résulte des forces de réaction du sol verticales et horizontales (A-P), et par un profil de locomotion déterminé par l'angle du tibia.
Les conditions de mise en charge d'essai spécifiées dans le présent document se caractérisent par les formats type de ces profils de chargement 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.
Le présent document définit les plages d'essai (R) en spécifiant les profils de locomotion pour l'essai cyclique, en accord avec l'usage prévu. Néanmoins, le concept des essais du présent document permet que chaque échantillon d'ensemble cheville-pied ou d'unité de pied soumis à l'essai développe ses propres performances lorsqu'il est mis en charge.
Le présent document permet d'évaluer et de soumettre à l'essai des unités de pied et des ensembles cheville-pied prothétiques conformément aux exigences de résistance spécifiées en 4.4 de l'ISO 22523:2006 (voir NOTE). 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 10328:2016, sont réputés conformes au présent document.
NOTE Les lignes de charges des forces au talon et à l'avant-pied générées par le mode opératoire d'essai statique pour la plage d'essai 4 (R4) spécifié dans le présent document, sont comparables aux efforts dans le plan sagittal respectivement définis dans les conditions de mise en charge d'essai I et II des essais principaux de structure de l'ISO 10328:2016, sans changer les valeurs des angles de la ou des plates-formes du talon et de l'avant-pied pour les essais de structure portant sur les ensembles cheville-pied et les unités de pied spécifiés dans l'ISO 10328:2016.
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo - Zahteve in preskusne metode (ISO 22675:2024)
General Information
Relations
Standards Content (Sample)
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
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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 cond
...
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