oSIST prEN ISO 22675:2022

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO/DIS 22675:2021)

ISO 22675:2006 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.
In addition, ISO 22675:2006 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, 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.

Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und Prüfverfahren (ISO/DIS 22675:2021)

Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et méthodes d'essai (ISO/DIS 22675:2021)

L'ISO 22675:2006 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.
En outre, l'ISO 22675:2006 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 de résistance à la rupture. L'essai se distingue, entre autres, 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.

Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo - Zahteve in preskusne metode (ISO/DIS 22675:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 27-Feb-2022
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 05-Sep-2024
• Due Date: 10-Sep-2024
• Completion Date: 05-Sep-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN ISO 22675 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)

Relations

• Revised: SIST EN ISO 22675:2016 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
• Effective Date: 19-Jan-2023
• Revised: SIST EN ISO 22675:2016 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
• Effective Date: 18-Jan-2023
• Revised: SIST EN ISO 22675:2016 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
• Effective Date: 16-Oct-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2022
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo -
Zahteve in preskusne metode (ISO/DIS 22675:2021)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test
methods (ISO/DIS 22675:2021)
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und
Prüfverfahren (ISO/DIS 22675:2021)
Prothèses - Essais d'articulations cheville-pied et unités de pied - Exigences et
méthodes d'essai (ISO/DIS 22675:2021)
Ta slovenski standard je istoveten z: prEN ISO 22675
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.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 22675
ISO/TC 168 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-12-23 2022-03-17
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
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 22675:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021

ISO/DIS 22675:2021(E)
© ISO 2021
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.
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Published in Switzerland
ii
ISO/DIS 22675:2021(E)
Contents Page
Foreword . vi
Introduction .viii
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 . 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 . 7
6.7.3 Effective ankle-joint centre, C . 7
A
7 Test loading conditions and test loading levels . 8
7.1 Test loading conditions . 8
7.2 Test loading levels and Test Ranges . 9
8 Values of test forces, dimensions and cycles .10
9 Compliance .18
9.1 General . 18
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 . 19
9.2.1 Arrangements for testing . 19
9.2.2 Requirements for claiming compliance . 19
9.3 Number of tests and test samples required to claim compliance with this document . 19
9.4 Multiple use of test samples . . 19
9.4.1 General . 19
9.4.2 Restriction .20
9.5 Testing at particular test loading levels not specified in this document .20
10 Test samples .21
10.1 Selection of test samples . 21
10.1.1 General . 21
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot . 21
10.2 Types of test sample . .22
10.2.1 Complete structure . 22
10.2.2 Partial structure .22
10.3 Preparation of test samples . 22
10.4 Identification of test samples . 22
10.5 Alignment of test samples .22
10.6 Worst-case alignment position of test samples . 23
11 Responsibility for test preparation .25
12 Test submission document . .26
12.1 General requirements .26
12.2 Information required for test samples . 26
12.3 Information required for tests . 27
iii
ISO/DIS 22675:2021(E)
12.3.1 General . 27
12.3.2 For all tests . 27
12.3.3 For the static proof test and the static ultimate strength test . 27
12.3.4 For the static ultimate strength test . 27
12.3.5 For the cyclic test . 27
13 Equipment .28
13.1 General .28
13.2 End attachments .28
13.2.1 General .28
13.2.2 Proof test of end attachments.28
13.3 Jig (optional) . 31
13.4 Test equipment . 31
13.4.1 Test equipment to perform static heel and forefoot loading . 31
13.4.2 Test equipment to perform cyclic loading . 32
14 Accuracy .38
14.1 General .38
14.
...