oSIST prEN ISO 22523:2026

SLOVENSKI STANDARD
01-april-2026
Proteze zunanjih okončin in zunanje ortoze - Zahteve in preskusne metode
(ISO/DIS 22523:2026)
External limb prostheses and external orthoses - Requirements and test methods
(ISO/DIS 22523:2026)
Externe Gliedmaßenprothesen und externe Orthesen- Anforderungen und Prüfverfahren
(ISO/DIS 22523:2026)
Prothèses de membre externes et orthèses externes - Exigences et méthodes d'essai
(ISO/DIS 22523:2026)
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 22523.2
ISO/TC 168
External limb prostheses and
Secretariat: DIN
external orthoses — Requirements
Voting begins on:
and test methods
2026-02-26
Prothèses de membre externes et orthèses externes — Exigences
Voting terminates on:
et méthodes d'essai
2026-04-23
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 22523.2:2026(en)
DRAFT
ISO/DIS 22523.2:2026(en)
International
Standard
ISO/DIS 22523.2
ISO/TC 168
External limb prostheses and
Secretariat: DIN
external orthoses — Requirements
Voting begins on:
and test methods
Prothèses de membre externes et orthèses externes — Exigences
Voting terminates on:
et méthodes d'essai
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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Published in Switzerland Reference number
ISO/DIS 22523.2:2026(en)
ii
ISO/DIS 22523.2:2026(en)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Risk management .2
4.2 Intended performance and technical documentation .3
4.3 Clinical evaluation .3
4.4 Strength and related conditions of use .3
5 Requirements for materials . 5
5.1 Flammability of materials and toxicity of combustion products .5
5.2 Biocompatibility, contaminants and residues .5
5.2.1 General .5
5.2.2 Contaminants and residues .5
5.3 Infection and microbial contamination .5
5.4 Resistance to corrosion and degradation .5
6 Noise and vibration . 6
7 Electromagnetic compatibility (EMC) . . 6
8 Electrical safety . 6
8.1 Battery-powered prosthetic and orthotic devices .6
8.1.1 Battery housings and connections .6
8.1.2 Charge level indicators .6
8.2 Circuit protection .7
8.3 Electronic programmable systems .7
8.4 Electrically heated blankets, pads and similar flexible heating appliances .7
8.5 Prosthetic and orthotic devices with skin contact electrodes .7
8.6 Prosthetic and orthotic devices with radio equipment .7
8.6.1 General .7
8.6.2 Frequency spectrum of radio equipment .7
8.6.3 Operation of radio equipment by the user.7
9 Surface temperature . . 7
10 Design requirements . 8
10.1 Safety of moving parts .8
10.2 Safety of connections .8
11 Mechanical requirements . 8
11.1 Restrictions on use .8
11.2 Forces in soft tissues of the human body .8
11.3 Ergonomic principles .9
12 Information supplied by the manufacturer . 9
12.1 General .9
12.2 Labelling .9
12.3 Intended use .9
13 Packaging. 10
Annex A (informative) Guidance on methods of determining the strength of upper-limb
prosthetic devices . .11
Annex B (informative) Guidance on methods of determining the mechanical properties of knee
joint assemblies for lower-limb orthotic devices .25

iii
ISO/DIS 22523.2:2026(en)
Annex C (informative) Guidance on methods of determining the flammability and toxicity of
combustion products of lower-limb prosthetic devices .26
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 .39
Annex E (informative) Reference to the essential principles of safety and performance of
medical devices in accordance with ISO/TR 16142 .63
Annex F  Symbols specifying the environmental conditions that prosthetic or orthotic
components can withstand .65
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .67
Bibliography .70

iv
ISO/DIS 22523.2:2026(en)
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, the technical documentation has been revised;
— update of 5.2.1 on biocompatibility;
— the content of former Annex B has been 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.

v
DRAFT International Standard ISO/DIS 22523.2:2026(en)
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 to 06 15 Orthoses
06 18 to 06 24 Limb prostheses
This document 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 guidance in the design and test of custom build orthosis and prosthesis.
NOTE The use 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 10328, Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 15032, Prostheses — 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
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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8548, ISO 8549, ISO 13404,
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
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

ISO/DIS 22523.2:2026(en)
3.2
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
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 intended to be used as
part of the technical documentation required by the Medical Devices Directive for conformity assessment
procedures
3.6
clinical evaluation
a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical
data to verify the safety, clinical performance and/or effectiveness of the device when use as intended by the
manufacturer
[SOURCE: IMDRF MDCE WG/N56FINAL:2019]
3.7
clinical investigation
systematic investigation in one or more human subjects, undertaken to assess the clinical performance,
effectiveness or safety of a medical device
[SOURCE: ISO 14155:2020, 3.8, modified – Note 1 to entry has been removed.]
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.
ISO/DIS 22523.2:2026(en)
NOTE 1 ISO 14971 can be used as guidance.
NOTE 2 Using 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.
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.
4.3 Clinical evaluation
Any clinical investigation shall be performed in accordance with ISO 14155.
The judgement of CPO (certified prosthetist and orthotist) and biomechanical engineers is particularly
relevant and should be taken into account when clinically evaluating prostheses and orthoses.
There is insufficient 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 the 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 conform with the requirement(s) of 4.4.1, the 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, ISO 22675 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.
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;

ISO/DIS 22523.2:2026(en)
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.
NOTE 1 An upper-limb prosthetic device can be tested, if appropriate, using the methods specified in Annex A.
NOTE 2 An orthotic device can be tested, if appropriare, using the methods specified in Annex B.
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 conform
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 conform 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).
ISO/DIS 22523.2:2026(en)
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 might 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.
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. The appropriate level for testing can be determined by the manufacturer.
IEC 60601-1 shall apply 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 no 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, can be affected
by corrosion and/or degradation, risk analysis shall be used to determine the most appropriate protective
measures.
For any corrosion test, the risk of combined stress and corrosion should be considered.

ISO/DIS 22523.2:2026(en)
Annex F provides a list of symbols to describe the environmental conditions that prosthetic or orthotic
components can withstand. For prosthetic components, the symbols shall be included in instructions
for use, and they should be included in catalogues, brochures, marketing materials, and other product
advertisements. For orthotic components, the use of the symbols is suggested. Symbols are not required on
the component or component data label.
NOTE ISO 9227, ASTM G85 or ASTM B117 might be used for the assessment of corrosion resistance of metallic
materials.
6 Noise and vibration
There are no specific requirements for prosthetic and orthotic devices except for medical electrical
equipment
NOTE IEC 60601-1 can IEC 60601-11 be used for a guidance for medical electrical equipment.
7 Electromagnetic compatibility (EMC)
Where relevant, a prosthetic or orthotic device shall satisfy the EMC requirements by conforming with
IEC 60601-1-2.
Manufacturers should consider the electromagnetic environments in which their products are likely to be
used and the possible consequences of malfunction.
Where relevant, prosthetic and orthotic devices may be used in the presence of other electronic equipment.
The electromagnetic compatibility (EMC) should be carefully matched to the environment in which the
device is intended to be used.
When specifying the EMC performance of the device, manufacturers should recognize the already widely
accepted environments of
— residential, commercial and light industrial;
— industrial;
— other (typically meaning more harsh environments and some specific places such as hospitals or near
specific machinery, e.g. transmitters and security scanners in public and other places).
8 Electrical safety
8.1 Battery-powered prosthetic and orthotic devices
8.1.1 Battery housings and connections
Battery housings and connections incorporated in a prosthetic or orthotic device shall conform with the
requirements of IEC 60601-1.
NOTE IEC 60601-1 and IEC 60601-1-11 can be used as guidance.
8.1.2 Charge level indicators
If the safety of the user depends upon the internal power supply of a prosthetic or orthotic device, that device
shall be equipped with a means of indicating the state of the power supply prior to the critical state which
results in an unacceptable risk.
NOTE IEC 60601-1 can be used as a guidance.

ISO/DIS 22523.2:2026(en)
8.2 Circuit protection
If the power supply of a prosthetic or orthotic device can be overloaded in use and the overload can cause a
risk to the user, that device shall be protected against the overload.
NOTE IEC 60601-1 can be used as a guidance.
8.3 Electronic programmable systems
A prosthetic or orthotic device incorporating electronic programmable systems shall be designed to ensure
the repeatability, reliability and performance of the systems according to their intended use.
Any software which can be used to control an electronic programmable system shall be designed to ensure
its repeatability, reliability and performance according to its intended use.
NOTE IEC 60601-1,, IEC 62304 and IEC 62366 can be used as a guidance.
8.4 Electrically heated blankets, pads and similar flexible heating appliances
A prosthetic or orthotic device that incorporates flexible heating appliances should conform to the
requirements of IEC 80601-2-35.
8.5 Prosthetic and orthotic devices with skin contact electrodes
The manufacturer shall conduct a risk analysis to assess the safety risks related to the use of skin contact
electrodes incorporated in a prosthetic or orthotic device used for nerve and muscle stimulation.
NOTE IEC 60601-1 can be used as guidance.
8.6 Prosthetic and orthotic devices with radio equipment
8.6.1 General
Radio equipment incorporated in and/or used together with a prosthetic or orthotic device shall conform
with the relevant requirements of IEC 60601-1.
8.6.2 Frequency spectrum of radio equipment
Radio equipment incorporated in and/or used together with a prosthetic or orthotic device shall be so
constructed that the frequency spectrum used does not cause harmful interference, i.e. interference
which endangers the functioning of radio navigation service or of other safety services or which otherwise
seriously degrades, obstructs or repeatedly interrupts a radio communications service operating.
8.6.3 Operation of radio equipment by the user
The manufacturer shall assess the particular conditions of operation of radio equipment incorporated in
and/or used together with a prosthetic or orthotic device with respect to the capabilities of the intended
user and regard the results in his decision on the appropriate design of control units or elements.
9 Surface temperature
A prosthetic or orthotic device may contain units which absorb energy and therefore rise in temperature
during normal intended use resulting in the risk of injury to the user touching the device.
The possibility of a temperature rise which may impair comfort should be investigated.
Wherever possible, a device such as that referred to in the first paragraph shall be provided with a means of
protection to remove or minimize the risk.

ISO/DIS 22523.2:2026(en)
If means of protection cannot be incorporated in such a device, clear warnings shall be given either on the
device or with the instructions for use (see Clause 12).
NOTE IEC 60601-1 can be used as a guidance.
10 Design requirements
10.1 Safety of moving parts
NOTE 1 Due to the nature of its intended purpose, some parts of a prosthetic or orthotic device can be required to
move relative to each other and as a result can trap and damage parts of the body or clothing of users or other persons.
Wherever possible such a device shall be provided with means of protection to remove or minimize the risk
during normal intended use.
NOTE 2 ISO 14971 provides one approach for a risk management which might be useful.
Wherever possible such a device shall be provided a cover to avoid entrapment for human fingers.
If a means of protection cannot be incorporated in such a device, clear warnings shall be given either on the
device or with the instructions for use (see Clause 13).
NOTE 3 Annex E gives guidance on reference to the essential principles of safety and performance of medical
devices in accordance with ISO/TR 16142.
10.2 Safety of connections
The terminals and connectors to the electric and/or fluid energy supplies or other connections of a prosthetic
or orthotic device which the user requires to handle shall be designed and constructed in such a way as to
minimize risk to the user. The reliability of the connector during the life of the product should be considered.
NOTE IEC 60601-1 can be used as a guidance.
11 Mechanical requirements
11.1 Restrictions on use
If a prosthetic or orthotic device can be produced by combining components or assemblies of components
from different manufacturers, the combination shall satisfy the requirements in 11.1.2.
The manufacturer of a component and/or assembly of components shall provide information on the other
components which are known to be suitable for use in combination (see Clause 12).
The manufacturer of a component and/or assembly of components shall provide information on any limitation
on the use of a prosthetic or orthotic device to any specific parameter such as loading (see Clause 12).
The risk of incompatibility between components used in the device shall be evaluated.
NOTE 1 ISO 14971 provides one approach for a risk management which might be useful.
NOTE 2 ISO 24562 provides guidance on the choice of geometrical aspects of pyramidal adapters.
11.2 Forces in soft tissues of the human body
Prosthetic and orthotic devices by the nature of their functions require to apply forces to the body segments
to which they are attached. The interface components of devices should be designed to avoid unacceptable
pressure on and stress levels in body tissues.
Mechanically based risks to tissue can include the following:

ISO/DIS 22523.2:2026(en)
— cell necrosis due to restricted nutrition and oxygen supply;
— tissue breakdown due to mechanical overload;
— tissue breakdown due to fatigue;
— tissue wear due to abrasion;
— cell destruction due to thermal coagulation.
11.3 Ergonomic principles
If the operation of a prosthetic or orthotic device requires the user to apply a force or moment to an actuator,
the manufacturer shall ensure that the magnitude of the required force or moment is suitable for the user.
Prosthetic and orthotic devices should be designed on ergonomic principles taking into account the special
needs of the intended user. If a device or one of its components or assemblies of components requires
adjustment or operation by the user, the means of adjustment or operation should be easily accessible and
ergonomically practicable for the user.
NOTE 1 Annex D describes methods of establishing the force or moment required to operate the control and
actuating mechanisms on prosthetic and orthotic devices and can be used as guidance.
It has been found in practice that the minimum value of the operating force or moment to be applied by the
user to the actuator of the control or actuating mechanism of a complete prosthetic or orthotic device should
.
be at least 5 N or 0,1 N m in order to avoid accidental operation of that control or actuating mechanism.
NOTE 2 For further information on ranges of operating force or moment measured on samples of orthotic knee and
elbow joints, prosthetic knee and elbow units and prosthetic terminal devices, see Clause D.6.
12 Information supplied by the manufacturer
12.1 General
12.1.1 The information supplied with a prosthetic or orthotic device shall conform to the requirements
of ISO 20417.
12.1.2 The information supplied with a prosthetic or orthotic device shall include those of the items
addressed or specified in 4.4.6, 4.4.8, 4.4.9, 5.1.2, 5.3, Clause 9, 10.1 and 11.1, which are relevant to that
device.
If appropriate, the user should be advised that the safety and lifetime of the prosthetic or orthotic device
depends upon the level of his/her activity while using the device (see 4.2).
12.1.3 If a prosthetic or orthotic device uses visual, audible or other sensible (sensory) signals to indicate
operating or adjusting parameters, the manufacturer shall ensure that the meaning of these signals is
understandable to the user and other involved persons.
NOTE IEC 62366-1 and ISO 14971 can be used as a guidance.
12.2 Labelling
Labelling shall follow the requirements of ISO 20417.
12.3 Intended use
12.3.1 The written instructions on the intended use of a prosthetic or orthotic device, supplied by the
manufacturer with the device, shall comprise at least

ISO/DIS 22523.2:2026(en)
a) specification of prosthetic or orthotic body location,
b) for prosthesis, specification of the permissible maximum values of principal loading parameters or
permissible threshold values of other relevant conditions of use, which limit the loads allowed to be
exerted on the prosthetic device during use by amputees or other persons with a physical handicap,
who are intended to be fitted with this device (see 4.4.7, 4.4.8 and 4.4.9), and
c) statement of the assemblies and/or alignments in which the prosthetic or orthotic device can be used
(see 12.1).
12.3.2 If specific requirements for the instructions on the intended use are included in the relevant
standard(s) and/or specification(s) listed in 4.4.3 and addressed in 4.4.4 and 4.4.5, these shall apply.
13 Packaging
Manufacturers should address the need for protective packaging.
The packaging of a prosthetic or orthotic device is intended to provide appropriate protection against
damage, deterioration or contamination during storage and transportation to the point of use. The various
forms of storage and the types of transportation that might be encountered therefore should be considered,
and the effectiveness of the packaging checked.

ISO/DIS 22523.2:2026(en)
Annex A
(informative)
Guidance on methods of determining the strength of upper-limb
prosthetic devices
A.1 General
...