EN ISO 22523:2006

SLOVENSKI STANDARD
01-marec-2007
1DGRPHãþD
SIST EN 12523:2000
3URWH]H]XQDQMLKRNRQþLQLQ]XQDQMHRUWR]H=DKWHYHLQSUHVNXVQHPHWRGH,62

External limb prostheses and external orthoses - Requirements and test methods (ISO
22523:2006)
Externe Gliedmaßenprothesen und externe Orthesen - Anforderungen und Prüfverfahren
(ISO 22523:2006)
Protheses de membre externes et ortheses externes - Exigences et méthodes d'essai
(ISO 22523:2006)
Ta slovenski standard je istoveten z: EN ISO 22523:2006
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
11.180.10 3ULSRPRþNLLQSULODJRGLWYH]D Aids and adaptation for
JLEDQMH moving
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 22523
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.040.40
English Version
External limb prostheses and external orthoses - Requirements
and test methods (ISO 22523:2006)
Prothèses de membre externes et orthèses externes - Externe Gliedmaßenprothesen und externe Orthesen -
Exigences et méthodes d'essai (ISO 22523:2006) Anforderungen und Prüfverfahren (ISO 22523:2006)
This European Standard was approved by CEN on 13 April 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22523:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 22523:2006) has been prepared by Technical Committee ISO/TC 168
"Prosthetics and orthotics" in collaboration with Technical Committee CEN/TC 293 "Assistive
products for persons with disability", the secretariat of which is held by SIS.

This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2007, and conflicting national standards shall
be withdrawn at the latest by April 2007.

This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 22523:2006 has been approved by CEN as EN ISO 22523:2006 without any
modifications.
ANNEX ZA
(informative)
Clauses of this European Standard addressing essential requirements
or other provisions of EU Directives.

This European Standard has been prepared under a mandate given to the European Community
and the European Free Trade Association and supports corresponding essential requirements of
EU Directive 93/42/EEC concerning medical devices and EU Directive 99/5/EC on radio equipment
and telecommunications terminal equipment.

WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this standard.

The clauses of this standard are likely to support requirements of Directive 93/42 EEC concerning
medical devices (see Table ZA.1) and of Directive 99/5/EC on radio equipment and
telecommunications terminal equipment (see Table ZA.2).

Compliance with this standard provides one means of conforming with the corresponding essential
requirements of the Directive concerned and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and EU Directive 93/42/EEC

Corresponding Comments
Clauses/sub-clauses of this
annexes/paragraphs of
European Standard
Directive 93/42/EEC concerning
medical devices — Annex I:
Essential requirements
All 1
All and specifically: 4.1, 5.1, 2 Specifically: risk management,
5.4, 7, 8.2, 8.3, 9, 11.1, 11.2 flammability/toxicity, corrosion/degradation,
EMC, battery-powered devices, surface
temperature, moving parts, connections
All and specifically 4.2 3 Specifically: intended performance
All and specifically 4.2, 4.4 4 Specifically: intended performance,
strength
All and specifically 13, 14 5 Specifically: information, packaging
All and specifically 4.1 6 Specifically: risk management
5.1, 5.2 7.1 Flammability/toxicity,
biocompatibility/contaminants/residues
5.2, 13, 14 7.2 Biocompatibility/contaminants/residues,
information, packaging
5.2.2, 5.4 7.3 Contaminants/residues,
corrosion/degradation
5.2, 5.4, 11.2 7.6 Biocompatibility/contaminants/residues,
corrosion/ degradation, connections
5.2, 5.3 8.1 Biocompatibility/contaminants/residues,
infection and microbiological contamination
14 8.6 Packaging
Table ZA.1 (continued)
Corresponding annexes/paragraphs Comments
Clauses/sub-clauses of this
of Directive 93/42/EEC concerning

European Standard
medical devices — Annex I:
Essential requirements
12.1, 13 9.1 Restrictions on use, information
7, 9, 11.1, 12.2,12.3 9.2 EMC, surface temperature, moving
parts, forces on soft tissues on the
human body, ergonomic principles
5.1, 8.2 , 8.4 9.3 Inflammability/toxicity, battery
powered devices
8.6
11.3.1 Protection against unintended
radiation
8.3 12.1 Electronic programmable systems
8.1, 8.2 12.2 Battery-powered devices
7 12.5 EMC
8 12.6 Electrical safety
11, 12 12.7.1 Design and mechanical requirements
6 Vibration
12.7.2
6 12.7.3 Noise
8.2, 11.2 12.7.4 Battery-powered devices, connections
9 12.7.5 Surface temperature
8.5 12.8.2 Skin contact electrodes stimulate by
means of electrical energy and may
be considered as energy supply in the
sense of ER 12.8
Information
13.1, 13.2 12.9
13 13 Information, packaging
10 13.6. l) Information on sterilization if specific
devices require to be sterilized for
particular applications
4.3 14 Clinical evaluation
Table ZA.2 — Correspondence between this European Standard and EU Directive 99/5/EC

Comments
Clauses/sub-clauses of this Corresponding annexes/paragraphs of

European Standard Directive 99/5/EC concerning radio
equipment and telecommunications
terminal equipment
8.1, 8.2, 8.3, 8.4, 8.7.1 Article 3.1 (a)

Article 3.1 (b)
7, 8.7.1
Article 3.2
8.7.2
8.7.3 Article 3.3 (f)
INTERNATIONAL ISO
STANDARD 22523
First edition
2006-10-01
External limb prostheses and external
orthoses — Requirements and test
methods
Prothèses de membre externes et orthèses externes — Exigences et
méthodes d'essai
Reference number
ISO 22523:2006(E)
©
ISO 2006
ISO 22523:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 22523:2006(E)
Contents Page
Foreword. vi
Introduction . vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements. 4
4.1 Risk management . 4
4.2 Intended performance and technical documentation. 5
4.3 Clinical evaluation . 5
4.4 Strength and related conditions of use. 5
5 Requirements for materials . 6
5.1 Flammability of materials and toxicity of combustion products . 6
5.2 Biocompatibility, contaminants and residues . 7
5.2.1 General. 7
5.2.2 Contaminants and residues. 7
5.3 Infection and microbiological contamination . 7
5.4 Resistance to corrosion and degradation. 7
6 Noise and vibration. 7
7 Electromagnetic compatibility (EMC) . 8
8 Electrical safety. 8
8.1 Battery-powered prosthetic and orthotic devices. 8
8.1.1 Battery housings and connections. 8
8.1.2 Charge level indicators . 8
8.2 Circuit protection. 9
8.3 Electronic programmable systems. 9
8.4 Electrically heated blankets, pads and similar flexible heating appliances. 9
8.5 Prosthetic and orthotic devices with skin contact electrodes . 9
8.6 Prosthetic and orthotic devices with radio equipment. 9
8.6.1 General. 9
8.6.2 Frequency spectrum of radio equipment.9
8.6.3 Operation of radio equipment by the user . 9
9 Surface temperature. 10
10 Sterility. 10
11 Design requirements . 10
11.1 Safety of moving parts . 10
11.2 Safety of connections. 10
12 Mechanical requirements. 10
12.1 Restrictions on use. 10
12.2 Forces in soft tissues of the human body . 11
12.3 Ergonomic principles . 11
13 Information supplied by the manufacturer . 11
13.1 General. 11
13.2 Labelling . 12
13.3 Intended use. 12
14 Packaging . 12
ISO 22523:2006(E)
Annex A (informative) Guidance on methods of determining the strength of upper-limb prosthetic
devices . 13
Annex B (normative) Method of determining the mechanical properties of knee joint assemblies
for lower-limb orthotic devices. 28
Annex C (informative) Guidance on methods of determining the flammability and toxicity of
combustion products of lower-limb prosthetic devices . 41
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. 55
Annex E (informative) Reference to the essential principles of safety and performance of medical
devices in accordance with ISO/TR 16142 . 80
Bibliography . 82

Figure A.1 — Test sample segment lengths . 15
Figure A.2 — Configuration of test 1 . 16
Figure A.3 — Configuration of test 2 and test 4. 17
Figure A.4 — Configuration of test 3 and test 5. 17
Figure A.5 — Examples of test sample configurations. 18
Figure B.1 — Example of a test rig design suitable for the application of the four-point loading
system . 34
Figure B.2 — Arrangements of the four-point loading system (continued on Figure B.3) . 35
Figure B.3 — Arrangements of the four-point loading system (continued from Figure B.2). 36
Figure B.4 — Test orientations for joint assemblies intended to restrain motion in four directions
mutually at right angles (see B.5.1). 37
Figure B.5 — Example of a bending moment/angular deflection curve: single-stage failure
(see 3.17, 3.18 and 3.19) . 38
Figure B.6 — Examples of a bending moment/angular deflection curve: two-stage failures
(see 3.17, 3.18 and 3.19) . 39
Figure C.1 — Test sample dimensions trans-femoral (above-knee) — Finished limb. 48
Figure C.2 — Test sample dimensions trans-tibial (below-knee) — Finished limb . 49
Figure C.3 — Test sample dimensions trans-femoral (above-knee) — Socket former. 50
Figure C.4 — Test sample dimensions trans-tibial (below-knee) — Socket former . 50
Figure C.5 — Radiant heat source test . 51
Figure C.6 — Flaming ignition source test. 52
Figure C.7 — Sample support frame and weighing platform . 53
Figure D.1 — Bowden cable arrangement during test . 69
Figure D.2 — Test set-up according to D.6.2 for sample category D.3.1 a) Orthotic knee joints
with locking mechanism. 70
Figure D.3 — Test set-up according to D.6.3 for sample category D.3.1 b) Orthotic elbow joints
with locking mechanism. 70
Figure D.4 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units
with locking mechanism (continued on Figure D.5). 71
Figure D.5 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units
with locking mechanism (continued from Figure D.4) . 72
iv © ISO 2006 – All rights reserved

ISO 22523:2006(E)
Figure D.6 — Test set-up according to D.6.5 for sample category D.3.1 d) Prosthetic elbow units
with locking mechanism . 72
Figure D.7 — Test set-up according to D.6.6 for sample category D.3.1 e) Prosthetic elbow units
with user-driven articulation. 73
Figure D.8 — Test set-up according to D.6.7 for sample category D.3.1 f) Terminal devices with
built-in closing function . 74
Figure D.9 — Test set-up according to D.6.8 for sample category D.3.1 g) Terminal devices with
built-in opening function. 75
Figure D.10 — Test set-up according to D.6.9 for sample category D.3.1 h) Terminal devices with
no built-in closing or opening function, actuated by force application. 76
Figure D.11 — Test set-up according to D.6.10 for sample category D.3.1 i) Terminal devices with
no built-in closing or opening function, actuated by torque application . 77
Figure D.12 — Test set-up according to D.6.11 for sample category D.3.1 j) Terminal devices with
break-open feature for emergency situations . 78
Figure D.13 — Test set-up according to D.6.12 for sample category D.3.1 k) Prosthetic devices
with fail-safe release unit, illustrated for a separable prosthetic adaptor plate. 79

Table A.1 — Number of tests and test samples required. 19
Table B.1 — Example of test report . 40
Table C.1 — Worked example of calculating the TTPD . 54
Table D.1 — Parameters of the test set-up for sample category D.3.1 a) . 60
Table D.2 — Parameters of the test set-up for sample category D.3.1 c) . 62
Table D.3 — Details of the test report. 67
Table D.4 — Values of actuating/operating force (and displacement) and moment measured on
different categories of test sample . 68
Table E.1 — Correspondence between this International Standard and the essential principles of
ISO/TR 16142 . 81

ISO 22523:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 22523 was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics.
vi © ISO 2006 – All rights reserved

ISO 22523:2006(E)
Introduction
This International Standard has been prepared in close collaboration with Technical Committee CEN/TC 293
Technical aids for disabled persons.
This International Standard represents the revised version of the Harmonized European Standard
EN 12523:1999 already implemented by the member countries of the European Union and the European Free
Trade Association in accordance with the CEN/CENELEC Internal Regulations. Consequently, these
regulations apply accordingly.
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this International
Standard.
This International Standard provides one means to demonstrate that external limb prostheses and external
orthoses, which are also medical devices, conform to the essential requirements outlined in general terms in
Annex 1 of the EU Directive 93/42/EEC on medical devices.
This International Standard also provides means to demonstrate that external limb prostheses and external
orthoses with radio equipment according to definition 3.8 conform to the essential requirements of the EU
Directive 99/5/EC on radio equipment and telecommunications terminal equipment.
This standard is not intended to provide a means of showing conformity with the requirements of any other
directive.
There are three levels of European Standard dealing with technical aids for disabled persons. These are as
follows, with level 1 being the highest:
Level 1: General requirements for technical aids
Level 2: Particular requirements for families of technical aids
Level 3: Specific requirements for types of technical aids.
Where standards for particular aids or groups of aids exist (level 2 or 3), the requirements of lower-level
standards take precedence over higher-level standards. Therefore, to address all requirements for a particular
aid, it is necessary to consult first, standards of the lowest available level.
This is a combined level 2- and 3-standard (lowest possible) for external limb prostheses and external
orthoses, as specified in the scope.
In this International Standard, in addition to the reference to existing test standards, test methods for several
types of prostheses and orthoses are specified in separate annexes A to D.
Annex ZA is included to show the parts of this European Standard which address the essential requirements
of EU Directives 93/42/EEC and 99/5/EC.
NOTE Although this International Standard does not contain references to the level 1-standard EN 12182 Technical
aids for disabled persons — General requirements and test methods, it is recommended that EN 12182 be consulted.

INTERNATIONAL STANDARD ISO 22523:2006(E)

External limb prostheses and external orthoses —
Requirements and test methods
1 Scope
This International Standard 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 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.
NOTE 1 It is intended to cover orthopaedic footwear (classification 06 33) in the future.
NOTE 2 The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 may be
appropriate.
2 Normative references
The following referenced documents are indispensable for the application 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 8548-1, Prosthetics and orthotics — Limb deficiencies — Part 1: Method of describing limb deficiencies
present at birth
ISO 8548-2, Prosthetics and orthotics — Limb deficiencies — Part 2: Method of describing lower limb
amputation stumps
ISO 8548-3, Prosthetics and orthotics — Limb deficiencies — Part 3: Method of describing upper-limb
amputation stumps
ISO 8549-1, Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses
and external orthoses
ISO 8549-2, Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses and
wearers of these prostheses
ISO 8549-3, Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to external orthoses
ISO 10328, Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
ISO 13404:2005, Prosthetics and orthotics — Classification and description of external orthoses and orthotic
components
ISO 22523:2006(E)
ISO 13405-1, Prosthetics and orthotics — Classification and description of prosthetic components —
Part 1: Classification of prosthetic components
ISO 13405-2, Prosthetics and orthotics — Classification and description of prosthetic components —
Part 2: Description of lower-limb prosthetic components
ISO 13405-3, Prosthetics and orthotics — Classification and description of prosthetic components —
Part 3: Description of upper-limb prosthetic components
ISO 15032, Prosthetics — Structural testing of hip units
ISO 22675, Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods
IEC 60335-2-17 Household and similar electrical appliances — Safety — Part 2-17: Particular requirements
for blankets, pads and similar flexible heating appliances
IEC 60601-1:1988, 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 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test
EN 1041, Information supplied by the manufacturer with medical devices
EN 50082-2, Electromagnetic compatibility (EMC) — Generic immunity — Part 2: Industrial environment
3 Terms and definitions
For the purposes of this document, the definitions of ISO 8548 Parts 1 to 3, ISO 8549 Parts 1 to 3 (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 Parts 1 to 3 together with the
following terms and definitions apply. The definitions are listed in the order of citation.
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 In this International Standard 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 International Standard the term “orthotic device” is used.
3.3
user
person using (wearing) the prosthetic or orthotic device
2 © ISO 2006 – All rights reserved

ISO 22523:2006(E)
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
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
[ISO 14155-1]
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
NOTE The definitions of 3.9 to 3.19 below primarily apply to Annex B.
3.9
knee joint
joint in the side member of a lower limb orthosis that allows movement in the principal plane of flexion of the
anatomical knee joint
3.10
side member
medial or lateral component of either one-piece or compound construction and including side pieces (uprights),
end pieces, joints or adjustment devices
3.11
joint assembly
knee joint with integral side members or with side members attached
3.12
parallel side member
side member whose individual above-knee and below-knee components have cross sections of essentially
constant dimensions
3.13
stepped side member
side member whose cross section, at a distance of more than 75 mm from either side of the axis of flexion, is
reduced to a smaller cross section of constant dimensions
3.14
bending deformation
angular deflection (3.15) of a joint assembly (3.11) upon application of a bending moment by a four-point
loading system (see Figures B.1, B.2 and B.3)
ISO 22523:2006(E)
3.15
angular deflection
measure of the bending deformation (3.14) (see Figures B.1, B.5 and B.6), angular deflection to be the sum of
the numerical values of angular rotation α and α of the two shafts which carry the mountings of the two pairs
1 2
of rollers acting on the ends of the test sample
3.16
limit of proportionality
point in a bending moment/angular deflection (3.15) relationship beyond which there is deviation from the
initial linear behaviour (see Figures B.5 and B.6)
3.17
bending stiffness
ratio of change of bending moment to corresponding change of angular deflection (3.15) within the region of
linear proportionality
3.18
maximum bending moment
M
max
bending moment at fracture or at which a further increase in the bending deformation of the test sample
results in either a decrease of the bending moment (see Figure B.5) or an increase in the rate of change of the
bending moment (see Figure B.6)
NOTE If, during a test, the bending moment is constant or decreases as the bending deformation increases, but a
secondary structure subsequently carries the load so that the bending moment and the bending deformation resume
increasing together, then the maximum bending moment is the first maximum that is observed in the test and the
contribution of any secondary structure is ignored (see Figure B.6)
3.19
bending deformation at the maximum bending moment
amount of the bending deformation (3.14) when the value of the bending moment is M
max
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 (see, for example, Table G.1 of
ISO 14971:2000).
NOTE 3 The results of the risk management process may be used to select from this International Standard the
requirements which apply.
4 © ISO 2006 – All rights reserved

ISO 22523:2006(E)
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.
4.3 Clinical evaluation
The extent and nature of any clinical evaluation shall be governed by the novelty of the design, materials,
method of manufacture and/or application in the judgement of a qualified person/body.
The prosthetic or orthotic device under evaluation shall be found to be acceptable in the judgement of a
qualified person/body.
The identity of the qualified person/body and the basis of the judgement shall be recorded in the
manufacturer's technical documentation (see 4.2).
NOTE Clinical evaluation can require clinical investigation, which can be conducted using ISO 14155-1 and
ISO 14155-2 as guidance.
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 NOTES 1 and 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;
ISO 22523:2006(E)
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.
a) The manufacturer shall specify the strength level(s) considered to be appropriate.
b) The manufacturer shall specify the method(s) of test to be applied, with the exception described in 4.4.5.
NOTE An upper-limb prosthetic device can be tested, if appropriate, using the methods specified in Annex A as
guidance.
c) The manufacturer shall specify the test loading condition(s) and/or the test loading level(s) at which the
test(s) shall be conducted.
4.4.5 An orthotic knee joint assembly shall be tested, if appropriate, in accordance with the procedures
specified in Annex B.
NOTE These procedures are not intended for the testing of complete lower-limb orthotic devices.
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
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