prEN ISO 22523

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

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 22523:2006)

Prothèses de membre externes et orthèses externes - Exigences et méthodes d'essai (ISO 22523:2006)

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

• Status: Not Published
• Publication Date: 20-May-2024
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: CEN/TC 293 - Technical aids for disabled persons
• Drafting Committee: CEN/TC 293/WG 5 - Prosthoses and orthoses
• Current Stage: 3098 - Decision to reject - Consensus building
• Start Date: 13-Dec-2010
• Completion Date: 13-Dec-2010
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• 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: oSIST prEN ISO 22523:2022 - External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2022)

Relations

• Revises: EN ISO 22523:2006 - External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
• Effective Date: 19-Jan-2023

Overview

The prEN ISO 22523 standard, titled External Limb Prostheses and External Orthoses - Requirements and Test Methods (ISO 22523:2006), developed by CEN, establishes essential requirements and testing protocols for external limb prosthetic and orthotic devices. This standard covers classifications outlined in ISO 9999 ranging from orthoses (06 03 to 06 15) to limb prostheses (06 18 to 06 27). It focuses on ensuring the strength, material safety, usage restrictions, risk management, and comprehensive information provision for components and device assemblies under normal usage.

This standard does not address special seating, as it falls outside the orthosis classification and is generally not worn on the body. The document supports manufacturers, clinicians, and regulators in maintaining consistent safety, functionality, and biocompatibility standards for prosthetic and orthotic devices.

Key Topics

• Risk Management and Performance
  The standard mandates thorough risk assessment aligned with intended device performance to ensure safe usage conditions.

• Material Safety and Biocompatibility
  Materials used must be tested and certified regarding flammability, toxicity of combustion products, contamination levels, microbial safety, and resistance to corrosion and degradation.

• Mechanical Strength Requirements
  Prostheses and orthoses must undergo static and cyclic mechanical testing to verify their durability under various load and environmental conditions, considering ergonomic and anatomical factors.

• Electrical and Electromagnetic Safety
  For devices incorporating electrical components-including battery-powered prostheses, heating elements, electronics, or radio equipment-requirements cover battery safety, circuit protection, electromagnetic compatibility (EMC), and surface temperature control.

• Design and Assembly Safety
  Moving parts, connection mechanisms, and ergonomics are rigorously assessed to protect users against mechanical failure or injury.

• Information and Labelling
  Manufacturers must provide clear, comprehensive data about device use, safety instructions, limitations, and product labeling for user and healthcare provider guidance.

• Packaging Requirements
  Packaging must preserve device integrity and safety from manufacture to end-user delivery.

• Testing Procedures and Guidance
  Informative annexes supply detailed methodologies for testing upper limb prosthetic strength, knee joint assemblies in orthotic devices, and fire safety aspects.

Applications

The prEN ISO 22523 standard is crucial for:

• Manufacturers
  To guide device design, material selection, testing, and documentation fulfilling international safety and performance benchmarks.

• Healthcare Providers and Clinicians
  To verify prosthetic and orthotic devices meet safety and functional requirements, ensuring patient well-being.

• Regulatory Bodies and Certifiers
  To enforce compliance and harmonize safety regulations across medical device markets.

• Researchers and Developers
  To support innovation in prosthetics and orthotics through standardized testing and performance evaluation frameworks.

• Users of Prosthetic and Orthotic Devices
  To assure reliability and safety from prescribed assistive technology products.

Related Standards

• ISO 9999 – Classification of assistive products for persons with disabilities, providing framework codes referenced in ISO 22523.

• ISO 13485 – Medical devices quality management systems applicable to manufacturers of limb prostheses and orthoses.

• ISO 10993 – Biological evaluation of medical devices, relevant to material biocompatibility requirements.

• IEC 60601 Series – Electrical safety standards pertinent to devices with electronic or battery-powered components.

• ISO 22523 Annexes – Guidance documents within the standard provide test methods that align with international best practices for mechanical and safety evaluations.

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Keywords: ISO 22523, external limb prostheses, external orthoses, prosthetic device testing, orthotic device requirements, mechanical strength standards, biocompatibility, risk management, medical device safety, prosthetics and orthotics standards, CEN standards.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

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.

© 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.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
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
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
iv © ISO 2022 – All rights reserved

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
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

vi © ISO 2022 – All rights reserved

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/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, Medical electrical equipment — Part 1: General requirements for safety
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance – Collateral standard: Usability
ISO/DIS 22523:2022(E)
IEC 60601-1-11, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance - Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 62304, Medical device software — Software life cycle processes
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 80601-2-35 Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and
essential performance of heating devices using blankets, pads or mattresses and intended for heating in
medical use
CISPR 11, Industrial, scientific and medical equipment — Radio-frequency disturbance characteristics —
Limits and methods of measurement
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8548, ISO 8549 (except the
definitions for the terms “(external limb) prosthetic device” and “(external) orthotic device”, ISO 13404
(except the definitions for the terms “side member” and 'joint assembly') and ISO 13405 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
(external limb) prosthetic device
external limb prosthesis
externally applied device consisting of a single component or an assembly of components used to replace
wholly, or in part, an absent or deficient lower or upper-limb segment
Note 1 to entry: In this document the term “prosthetic device” is used.
3.2
(external) orthotic device
external orthosis
externally applied device consisting of a single component or an assembly of components applied to the
whole or part of the lower limb, upper-limb, trunk, head or neck and their intermediate joints to assist
the neuro-muscular and skeletal systems
NOTE In this document the term “orthotic device” is used.
3.3
user
person using (wearing) the prosthetic or orthotic device
3.4
attendant
person who assists the user
3.5
technical documentation
manufacturer's record of data showing conformity of a prosthetic or orthotic device with the
requirements of this International Standard and which is intended to be used as part of the technical
documentation required by the Medical Devices Directive for conformity assessment procedures
2 © ISO 2022 – All rights reserved

ISO/DIS 22523:2022(E)
3.6
clinical evaluation
means for confirming that a prosthetic or orthotic device conforms to the requirements of the Medical
Devices Directive by a compilation of clinical data that includes any scientific literature and the results of
any clinical investigations, taking into account any relevant Harmonized Standards
3.7
clinical investigation
any systematic study in human subjects, undertaken to verify the safety and performance of a specific
medical device, under normal conditions of use
[SOURCE: ISO 14155]
3.8
radio equipment
product or relevant component thereof, capable of communication by means of the emission and/or
reception of radio waves utilizing the spectrum allocated to terrestrial/space radio communication
3.9
leg dummy
part of the test setup, which mimics the orthosis users leg
4 General requirements
4.1 Risk management
Possible hazards associated with a prosthetic or an orthotic device can endanger the user. For this reason
the manufacturer shall establish and maintain a process for identifying those hazards and evaluating the
associated risks, controlling these risks and monitoring the effectiveness of the control. This risk
management process shall include the following elements:
risk analysis;
risk evaluation;
risk control;
post-production information.
NOTE 1 ISO 14971 can be used as guidance.
NOTE 2 Application of ISO 14971, as guidance, does not require that the manufacturer has a formal quality system
in place. However, risk management can be an integral part of a quality system.
NOTE 3 The results of the risk management process may be used to select from this document the requirements
which apply.
4.2 Intended performance and technical documentation
The intended performance including, where appropriate, strength and durability of a prosthetic or
orthotic device shall be described in the technical documentation which sets out its functional
characteristics, its application(s) and conditions of use.
The technical documentation shall include, where appropriate, references to relevant clinical and
scientific literature, any strength and/or life calculations, appropriate standards and test results.
The technical documentation shall specifically include a statement about the life time of the device. The
number of test cycles a device underwent, e. g. when tested in accordance with ISO 10328 or ISO 22675,
can be a useful indicator when determining the life time of the device.
ISO/DIS 22523:2022(E)
4.3 Clinical evaluation
Any clinical investigation shall be performed in accordance with ISO 14155.
The judgement of CPO and biomechanical engineers is particularly relevant and should be taken into
account when clinically evaluating prostheses and orthoses.
NOTE CPO is a certified prosthetist and orthotist.
There is insufficient historical data on a significant portion of prosthesis and orthosis which has been
placed on the market during past decades. Post market analysis of data by manufacture and organisation
are the source of continuous improvement and continuous development.
4.4 Strength and related conditions of use
4.4.1 A prosthetic or orthotic device shall have the strength to sustain the loads occurring during use by
amputees, or other persons with a physical handicap, in the manner intended by the manufacturer for
that device according to his written instructions on its intended use.
NOTE For further information see 5.4 and NOTE in 5.2.2.
4.4.2 In order to comply with the requirement(s) of 4.4.1, the appropriate/relevant requirements of
4.4.3 to 4.4.7 shall be met.
4.4.3 The strength of a lower-limb prosthetic device shall be determined by application of the relevant
tests specified in ISO 10328 (see NOTE 1 and NOTE 2), ISO 22675 (see NOTE 2) and/or ISO 15032 at a
specific test loading level.
NOTE 1 ISO 10328 does not include test methods for flexion testing of knee units with stance phase control
mechanisms.
NOTE 2 In order to allow continuity of testing by checking the test methods for ankle-foot devices and foot units
specified in ISO 22675 against those specified in ISO 10328, a transition period will be established, during which
both test methods are valid. For practical reasons this transition period will be adapted to the period of time after
which the systematic review of ISO 10328 and ISO 22675 is indicated. The systematic review of both standards is
expected to result, among other outcomes, in the finding on whether the test methods specified in ISO 22675 have
demonstrated their suitability.
4.4.4 The strength of all other prosthetic and orthotic devices shall be determined in the manner
specified in a) to d).
The justification for the manufacturer's selections in a) to d) shall be recorded in the technical
documentation (see 4.2).
a) The manufacturer shall specify which of the following category/categories of strength is/are
considered to be appropriate:
1) fatigue strength: the cyclic load which can be sustained for a prescribed number of cycles;
2) proof strength: the static load representing an occasional severe event, which can be
sustained and still allow the prosthetic or orthotic device to function as intended;
3) ultimate strength: the static load representing a gross single event, which can be
sustained but which might render the prosthetic or orthotic device thereafter unusable.
b) The manufacturer shall specify the strength level(s) considered to be appropriate.
c) The manufacturer shall specify the method(s) of test to be applied, with the exception described
in 4.4.5.
4 © ISO 2022 – All rights reserved

ISO/DIS 22523:2022(E)
NOTE An upper-limb prosthetic device can be tested, if appropriate, using the methods specified in Annex A as
guidance.
d) The manufacturer shall specify the test loading condition(s) and/or the test loading level(s) at
which the test(s) shall be conducted. The specified loading condition(s) shall include the worst
case situation in relation to clinical indication and patient characteristics (remaining muscle
strength, deformities and contractures, spasticity, bodyweight etc.).
4.4.5 An orthotic assembly for the lower limb shall be tested in a validated test setup, which includes
a leg dummy to load the orthotic assembly as specified in 4.4.1. Functional properties of orthotic
devices, claimed by manufacturers / submitters, shall be quantified prior and after the cyclic test and
both shall be documented in the technical documentation.
NOTE Experience shows, that using a leg dummy which does not stabilize the orthotic assembly beyond
the stabilization the users leg applies, and footwear where appropriate, and testing the strength
category/categories in a static- or durability in a rollover scenario, are appropriate measures to apply the
required complex loadings to orthotic assemblies. The amount of loads applied during testing can be
obtained or validated through measurements using instrumented orthotic components (joints, bars etc.).
4.4.6 Details of the category/categories of strength and strength level(s) specified and details of the
tests, test loading conditions and/or test loading levels applied to the prosthetic or orthotic device shall
be given in the information supplied by the manufacturer (see Clause 13).
4.4.7 The manufacturer shall specify the loading conditions for a prosthetic or orthotic device to comply
with the requirements of 4.4.1. Reference shall be made to loading parameters and/or other conditions
of the intended use that can be quantified or that are known to be interpreted in a uniform way.
NOTE For lower-limb prosthetic devices, the body mass is the quantifiable loading parameter commonly referred
to.
The specification of these loading parameters and/or other relevant conditions of use shall take account
of the safety factors corresponding to the particular use of the prosthetic or orthotic device intended by
the manufacturer, which are determined by the ratio between the test loading conditions and/or test
loading levels applied to the device and the corresponding loads expected to be exerted on the device
during use by amputees or other persons with a physical handicap in the manner intended by the
manufacturer.
4.4.8 Details of the loading conditions for a prosthetic or orthotic device, specified by the manufacturer
in accordance with 4.4.7, shall be stated in the information supplied by the manufacturer with the device
(see Clause 13).
4.4.9 Details of the specific loading parameters and/or other relevant conditions of use according to
4.4.7, required to comply with the requirements of 4.4.1 for a prosthetic or orthotic device, shall be stated
in the written instructions on the intended use of that device, supplied by the manufacturer with the
device (see Clause 13).
5 Requirements for materials
5.1 Flammability of materials and toxicity of combustion products
5.1.1 In prosthetic or orthotic devices every effort shall be made to use materials which minimize the
risk of propagation of flames, as it is of particular importance to disabled persons who may not be able to
escape from a fire. The use of non-flame-retardant materials shall be regularly reviewed as there is
continuous development in this field.
ISO/DIS 22523:2022(E)
NOTE To test materials used in lower-limb prosthetic devices, the test methods specified in ISO 8191-1 or UL94
or Annex C can be used as guidance. The appropriate level for testing can be determined by the manufacturer.
IEC 60601-1 standard series shall be applied for medical electrical equipment. Only parts with a volume
of more than 500 mm shall be evaluated as a potential risk. The manufacturer shall evaluate any risk
resulting from the fume.
5.2 Biocompatibility, contaminants and residues
5.2.1 General
Materials that come into contact with the human body shall be assessed for biocompatibility, taking into
account the intended use and contact by those involved in user care or transportation and storage of the
product.
NOTE 1 Guidance for biological evaluation and selection of appropriate tests is given in ISO 10993-1.
NOTE 2 For some materials assessments using Standard 100 by OEKO-TEX® or the REACH Regulation can be useful
in ascertaining that not hazardous substances are included in them which in turn can be helpful when carrying out
the biological evaluation.
5.2.2 Contaminants and residues
The risk of substances leaking from the device shall be assessed.
NOTE 1 ISO 14971 provides one approach for a risk management which might be useful.
NOTE 2 Substance that can leak include lubricants, hydraulic fluids and battery fluids.
5.3 Infection and microbial contamination
The manufacturer shall specify the method and frequency by which a prosthetic or orthotic device and/or
the body surface to which it applies can be cleaned.
EXAMPLE Usually, devices are cleaned by the CPO or the patient with mild soap and clear water with a soft tissue.

The risk of infection or microbial contamination shall be evaluated.
NOTE ISO 14971 provides one approach for a risk management which might be useful.

Animal tissue products can carry infection and microbiological contamination, and manufacturers should
examine them for signs of disease or contamination. For more information see ISO 22442-1.

5.4 Resistance to corrosion and degradation
If the strength of a prosthetic or orthotic device, or the safety of the user or an attendant,
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