oSIST prEN ISO 22523:2022
(Main)External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2022)
External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2022)
ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
06 03 - 06 15 Orthoses06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.
Externe Gliedmaßenprothesen und externe Orthesen – Anforderungen und Prüfverfahren (ISO/DIS 22523:2022)
Prothèses de membre externes et orthèses externes - Exigences et méthodes d'essai (ISO/DIS 22523:2022)
L'ISO 22523:2006 spécifie les exigences et les méthodes d'essai applicables aux prothèses de membre externes et orthèses externes, y compris les classifications suivantes de l'ISO 9999:
06 03 - 06 15 Orthèses06 18 - 06 27 Prothèses de membre
Elle couvre la résistance, les matériaux utilisés, les restrictions d'utilisation, les risques et les informations associés aux conditions normales d'utilisation des composants et des ensembles de composants.
La présente Norme internationale ne traite pas des «corsets-sièges» car ils ne sont pas classés comme orthèses dans l'ISO 9999 et ne sont pas normalement portés sur le corps.
Proteze zunanjih okončin in zunanje ortoze - Zahteve in preskusne metode (ISO/DIS 22523:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 22523:2022
01-julij-2022
Proteze zunanjih okončin in zunanje ortoze - Zahteve in preskusne metode
(ISO/DIS 22523:2022)
External limb prostheses and external orthoses - Requirements and test methods
(ISO/DIS 22523:2022)
Externe Gliedmaßenprothesen und externe Orthesen – Anforderungen und
Prüfverfahren (ISO/DIS 22523:2022)
Prothèses de membre externes et orthèses externes - Exigences et méthodes d'essai
(ISO/DIS 22523:2022)
Ta slovenski standard je istoveten z: prEN ISO 22523
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
oSIST prEN ISO 22523:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 22523:2022
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oSIST prEN ISO 22523:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 22523
ISO/TC 168 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-04-25 2022-07-18
External limb prostheses and external orthoses —
Requirements and test methods
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 22523:2022(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 2022
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oSIST prEN ISO 22523:2022
ISO/DIS 22523:2022(E)
ISO TC 168
ISO/DIS 22523:2022(E)
Date: 2022-02-18
External limb prostheses and external orthoses — Requirements
and test methods
DIS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
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.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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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© ISO 2022 – All rights reserved
Published in Switzerland
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© ISO 2022 – All rights reserved
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oSIST prEN ISO 22523:2022
ISO/DIS 22523:2022(E)
Contents
Foreword . vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 Risk management . 3
4.2 Intended performance and technical documentation . 3
4.3 Clinical evaluation . 4
4.4 Strength and related conditions of use . 4
5 Requirements for materials . 5
5.1 Flammability of materials and toxicity of combustion products. 5
5.2 Biocompatibility, contaminants and residues. 6
5.2.1 General . 6
5.2.2 Contaminants and residues . 6
5.3 Infection and microbial contamination . 6
5.4 Resistance to corrosion and degradation . 6
6 Noise and vibration . 7
7 Electromagnetic compatibility (EMC) . 7
8 Electrical safety . 7
8.1 Battery-powered prosthetic and orthotic devices . 7
8.1.1 Battery housings and connections . 7
8.1.2 Charge level indicators . 7
8.2 Circuit protection . 7
8.3 Electronic programmable systems . 8
8.4 Electrically heated blankets, pads and similar flexible heating appliances . 8
8.5 Prosthetic and orthotic devices with skin contact electrodes . 8
8.6 Prosthetic and orthotic devices with radio equipment . 8
8.6.1 General . 8
8.6.2 Frequency spectrum of radio equipment . 8
8.6.3 Operation of radio equipment by the user . 8
9 Surface temperature . 8
10 Design requirements . 9
10.1 Safety of moving parts . 9
10.2 Safety of connections . 9
11 Mechanical requirements . 9
11.1 Restrictions on use . 9
11.2 Forces in soft tissues of the human body . 9
11.3 Ergonomic principles . 10
12 Information supplied by the manufacturer . 10
12.1 General . 10
12.2 Labelling . 10
12.3 Intended use . 10
13 Packaging . 11
Annex A (informative) Guidance on methods of determining the strength of upper-limb
prosthetic devices. 12
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oSIST prEN ISO 22523:2022
ISO/DIS 22523:2022(E)
A.1 General .12
A.2 Principle.12
A.3 Test samples .12
A.3.1 General .12
A.3.2 Selection of test samples .12
A.3.3 Preparation of test samples .13
A.3.4 Alignment of test samples .17
A.3.5 Orientation marks on test samples .18
A.4 Number of tests and test samples required .18
A.5 Multiple use of test samples .18
A.5.1 General .18
A.5.2 Restriction .18
A.6 Test submission document .19
A.6.1 General requirements .19
A.6.2 Information required for test samples .19
A.6.3 Information required for tests .19
A.7 Accuracy .20
A.7.1 General .20
A.7.2 Accuracy of equipment .20
A.7.3 Accuracy of procedure.20
A.8 Static tests .20
A.8.1 General .20
A.8.2 Distal tensile test (Test 1) .21
A.8.3 Static downward bending test (Test 2) .21
A.8.4 Static upward bending test (Test 3) .22
A.9 Cyclic tests .23
A.9.1 General .23
A.9.2 Cyclic downward bending test (Test 4) .23
A.9.3 Cyclic upward bending test (Test 5) .24
A.10 Test report .25
A.10.1 General requirements .25
A.10.2 Specific requirements .25
A.10.3 Options .25
Annex B (informative) Guidance on methods of determining the mechanical properties of
knee joint assemblies for lower-limb orthotic devices .26
Annex C (informative) Guidance on methods of determining the flammability and toxicity
of combustion products of lower-limb prosthetic devices .27
C.1 General .27
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oSIST prEN ISO 22523:2022
ISO/DIS 22523:2022(E)
C.2 Principle . 27
C.3 Test submission document . 27
C.4 Safety requirements. 27
C.5 Test samples . 28
C.5.1 Sample, nature and source . 28
C.5.2 Sample identification . 28
C.5.3 Sample dimensions . 28
C.5.4 Sample conditioning . 28
C.6 Test arrangements . 28
C.6.1 Test room . 28
C.6.2 Sample support frame. 29
C.6.3 Apparatus . 29
C.6.3.1 Radiant heat source . 29
C.6.3.2 Flame ignition source . 30
C.6.3.3 Weighing platform . 30
C.6.3.4 Video/photographic recording . 30
C.7 Test procedures . 30
C.7.1 General . 30
C.7.2 Radiant heat source . 31
C.7.3 Flaming ignition source . 31
C.8 Determination of the “Total Toxic Potential Dose” (TTPD) . 32
C.8.1 Rationale for the toxicity criterion based on mass loss . 32
C.8.2 Calculation of the “Total Toxic Potential Dose” (TTPD) . 32
C.9 Pass/fail criteria . 33
C.9.1 Radiant heat source test . 33
C.9.2 Flaming ignition source test . 33
C.10 Test report . 33
Annex D (informative) Guidance on methods of establishing the force or moment required
to operate the control and actuating mechanisms on prosthetic and orthotic
devices . 41
D.1 General . 41
D.2 Principle . 41
D.3 Test samples . 42
D.3.1 Categories of test sample . 42
D.3.2 Preparation of test samples . 42
D.4 Number of required tests . 44
D.5 Accuracy . 44
D.6 Methods of testing . 44
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oSIST prEN ISO 22523:2022
ISO/DIS 22523:2022(E)
D.6.1 General .44
D.6.2 Test set-up for sample category .45
D.6.3 Test set-up for sample category .46
D.6.4 Test set-up for sample category .47
D.6.5 Test set-up for sample category .48
D.6.6 Test set-up for sample category .49
D.6.7 Test set-up for sample category .49
D.6.8 Test set-up for sample category .50
D.6.9 Test set-up for sample category .50
D.6.10 Test set-up for sample category .51
D.6.11 Test set-up for sample category .51
D.6.12 Test set-up for sample category .52
D.7 Test report .52
D.7.1 General requirements .52
D.7.2 Specific requirements .52
D.8 Test results .53
Annex E (informative) Reference to the essential principles of safety and performance of
medical devices in accordance with ISO/TR 16142 .64
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered.66
Bibliography .69
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oSIST prEN ISO 22523:2022
ISO/DIS 22523:2022(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 second edition cancels and replaces the first edition (ISO 22523:2006), which has been technically
revised.
The main changes are as follows:
in 4.2 it is now required to the technical documentation shall specifically include a statement
about the life time of the device;
5.2.1 was amended to reflect the fact that generally all materials that come into contact with
the human body have to be assessed for biocompatibility;
The content of Annex B was removed.
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.
© ISO 2022 – All rights reserved vii
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oSIST prEN ISO 22523:2022
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oSIST prEN ISO 22523:2022
ISO/DIS 22523:2022(E)
External limb prostheses and external orthoses — Requirements
and test methods
1 Scope
This document specifies requirements and test methods for external limb prostheses and external
orthoses, including the following classifications from ISO 9999:
06 03 - 06 15 Orthoses
06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with
the normal conditions of use of both components and assemblies of components. This document is also
applicable as a guide in the design and test of custom build orthosis and prosthesis.
NOTE The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 can be
appropriate.
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 edition of the referenced document (including any amendments) applies.
ISO 8191, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source:
smouldering cigarette
ISO 10328, Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15032, Prosthetics — Structural testing of hip units
ISO 20417, Medical devices — Information to be provided by the manufacturer
ISO 22675, Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods
ISO 24562, Prosthetics — Geometrical aspects of lower limb prosthetic adapters
IEC 60601-1, Medi
...
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