prEN ISO 22675

SLOVENSKI STANDARD
oSIST prEN ISO 22675:2022
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
oSIST prEN ISO 22675:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 22675:2022

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oSIST prEN ISO 22675:2022
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

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oSIST prEN ISO 22675:2022
ISO/DIS 22675:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Published in Switzerland
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oSIST prEN ISO 22675:2022
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
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oSIST prEN ISO 22675:2022
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
14.2 Accuracy of equipment .39
14.3 Accuracy of procedure . 39
15 Test principles .39
15.1 General .39
15.2 Static test procedure .40
15.3 Cyclic test procedure .44
16 Test procedures . 44
16.1 Test loading requirements .44
16.1.1 Preparation for test loading .44
16.1.2 Test loading conditions . 47
16.2 Static proof test .48
16.2.1 Test method .48
16.2.2 Performance requirement .50
16.2.3 Compliance conditions .50
16.3 Static ultimate strength test . 52
16.3.1 Test method . 52
16.3.2 Performance requirements .54
16.3.3 Compliance conditions .54
16.4 Cyclic test . 55
16.4.1 Test method . 55
16.4.2 Performance requirements .58
16.4.3 Compliance conditions .58
16.5 Separate static test in torsion . 61
16.5.1 General . 61
16.5.2 Purpose of test . 61
16.5.3 Test method . 61
16.5.4 Performance requirements . 62
16.5.5 Compliance conditions .63
17 Test laboratory/facility log .63
17.1 General requirements .63
17.2 Specific requirements .63
18 Test report .63
18.1 General requirements .63
18.2 Specific requirements .64
18.3 Options.64
19 Classification and designation .64
19.1 General .64
19.2 Example of classification and designation .64
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oSIST prEN ISO 22675:2022
ISO/DIS 22675:2021(E)
20 Compliance to Standard .65
20.1 General .65
20.2 Example of identifier layout .65
20.3 Identifier placement .65
Annex A (informative) Reference data for the specification of the test loading conditions
and test loading levels of this document .66
Annex B (informative) Guidance on the application of an alternative static ultimate
strength test .75
Annex C (informative) Application of an additional test loading level P6, P7, and P8 .76
Annex D (informative) Summary of the records to be entered in the test laboratory/facility
log .77
[1]
Annex E (informative) Information on Technical Report ISO/TR 22676 .83
Annex F (informative) Reference to the essential principles of safety and performance
of medical devices according to ISO/TR 16142 .95
Annex G (informative) Background Data (reduced) of the six minute walk test for Adults
(see [3]) .96
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .97
Bibliography .99
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oSIST prEN ISO 22675:2022
ISO/DIS 22675:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation 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.
This third edition cancels and replaces the second edition (ISO 22675:2016), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Test loading levels P7 and P8 have been introduced in Table 11, Table A.1, Table C.1, Table C.2 and the
clauses pointing at these tables have been updated or removed.
— Table 10 "Test forces for all tests and prescribed number of cycles for the cyclic test, for all test
loading levels and for all Test Ranges" has been revised.
— The content of Annex C has changed from informative to normative by moving it from Annex into
the standard.
— This edition specifies three Test Ranges by specifying locomotion profiles in combination with the
number of test cycles for the cyclic test in relation to the intended use. Furthermore it clarifies the
position of the Ankle joint related to the connecting device of ankle foot devices and it emphasizes
the fact, that the top load application point Pt shall not bear moments exceeding the accuracy defined
in this standard.
— This edition describes, how to consider testing ankle-foot-devices and foot units used in less
severe loading conditions than the average most active users do. Therefore this standard not only
distinguishes the test level (p-level) by the applied force (profile), but also the Test Range (R) by
different tilting or static plate angles.
— This edition takes into consideration, that technical development for example in the area of robotics
increase the availability for sensors, signal processors and control units, which can be used for the
defined test of this standard too. Therefore the coordinate systems for geometries and forces of this
Standard are adapted to the ISO definitions for robotics.
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oSIST prEN ISO 22675:2022
ISO/DIS 22675:2021(E)
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.
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oSIST prEN ISO 22675:2022
ISO/DIS 22675:2021(E)
Introduction
This document offers alternatives to the structural tests on ankle-foot devices and foot units specified
in 17.2 of ISO
...