kSIST FprEN ISO 10328:2026

• Abstract:

  IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to ISO 22675:2016.; WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.; ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.

• Status: Not Published
• Public Enquiry End Date: 08-Sep-2025
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 14-Aug-2026
• Due Date: 02-Oct-2026
• Completion Date: 24-Aug-2026
• 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
• 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
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: FprEN ISO 10328 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO/FDIS 10328:2026)

• Revises: SIST EN ISO 10328:2016 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
• Effective Date: 03-May-2023

kSIST FprEN ISO 10328:2026 is the SIST adoption of ISO/FDIS 10328:2026 for structural testing of lower-limb prostheses. It specifies static and cyclic strength tests, plus related torsion, ankle-foot, foot-unit and knee-flexion procedures, so manufacturers, submitters and test laboratories can assess a prosthetic device/structure for a defined intended use. It is for conformity testing, not for selecting a prosthesis for an individual amputee.

What does kSIST FprEN ISO 10328:2026 specify?

kSIST FprEN ISO 10328:2026 specifies procedures and test conditions for the structural strength assessment of lower-limb prostheses. The document covers compound loading created by a single test force, with the load components chosen to represent peaks that normally occur at different times during walking.

The scope applies to specific ankle-disarticulation prostheses, transtibial, knee-disarticulation and transfemoral prostheses, and the distal part of hip-disarticulation and hemi-pelvectomy prostheses. The test geometry is intended only up to 150 mm above the knee-joint centre, which matters when deciding whether a design falls within the method.

The document is organized into clauses on scope, normative references, terms, symbols, strength categories, coordinate systems and test configurations, loading conditions and values, compliance, samples, responsibility, submission documents, equipment, accuracy, test principles, principal and separate tests, logging, reporting, classification and designation, and compliance. Its annexes add background data, alternative geometries and regulatory context.

Annex	What it covers
Annex A	Internal loads and their effects
Annex B	Reference data for principal cyclic tests and Test Ranges (R)
Annex C	Guidance on the alternative static ultimate strength test
Annex D	Summary of records for the test laboratory/facility log
Annex E	Background on loading profiles for ankle-foot devices and foot units
Annex G	Additional loading level P2 and related test data
Annex H	Alternative test geometry from recent biomechanical studies
Annex ZA	Relationship with Regulation (EU) 2017/745

What are the key requirements of kSIST FprEN ISO 10328:2026?

kSIST FprEN ISO 10328:2026 is built around one safety concept: the manufacturer assigns a Test Range (R) from the written intended use, and the chosen tests must match that intended use and the stated body mass limit. In practice, this means the test claim is tied to a specific use case, not to all possible fittings or user profiles.

Strength categories and what they prove

Clause 5 and Table 2 define four strength categories: proof strength, ultimate strength, fatigue strength and static strength in torsion, plus security against slippage of clamped components. The proof and ultimate tests check single severe events, the cyclic test checks repeated walking-type loading, and the torsion test checks that clamped joints do not slip.

This matters because a prosthesis can pass one category and still need separate evidence for another. A buyer or quality manager should read the claimed P-level and Test Range alongside the exact test type.

Geometry, alignment and load application

Clauses 6 and 7 define the two test configurations, the rectangular coordinate system, the reference planes T, K, A and B, the reference points and the load line. The test force is a single compressive force applied through the specified top and bottom load application points.

This geometry controls where the sample is held and where the load acts. In practice, correct alignment is critical because the same force can create very different bending and twisting effects if the offsets are wrong.

Loads, levels and cycles

Clause 8 and Tables 4 to 13 specify the test forces, twisting moments, segment lengths, offsets, angles, load factors and the prescribed number of cycles. The document uses loading levels P2 to P8, with Annex G adding P2 for lower-load applications and Annex H giving an alternative geometry for guidance.

This is the part laboratories use to set up the machine. The reader should look here to know which load level applies, how many cycles are needed, and whether the claim uses the standard or alternative geometry.

Compliance claim and sample rules

Clause 9 says a compliance claim must be based on the relevant tests, the relevant loading conditions and levels, and a prescribed number of samples from an allowed batch. It also says the claim must state the test loading level and the Test Range (R) used.

Table 14 shows which combinations of principal and separate tests apply to complete structures, partial structures and individual components. Table 15 sets the minimum number of tests and samples, and Clause 10 requires worst-case alignment and appropriate sample selection.

In practice, this prevents a broad claim from being made on the basis of one convenient configuration. The claim is only as broad as the tested assembly and alignment.

Test execution, accuracy and repeat use

Clauses 11 to 16 set responsibilities, submission information, equipment, accuracy and the principal test principles. Equipment and measuring devices must be calibrated at least annually and after replacement, and the procedure tolerances cover dimensions, angles, forces, frequency and displacement.

This matters because the document is not just about the load values, but also about how repeatable the setup must be. The principal cyclic test ends with a final static test, and the principal static ultimate strength test also evaluates shock absorption capacity by comparing absorbed energy against a calculated reference.

Separate tests for specific components

Clause 17 adds separate tests for torsion, ankle-foot devices and foot units, maximum knee flexion for knee joints and associated parts, and optional knee-lock tests. The ankle-foot and foot-unit tests use heel and forefoot loading, and the torsion test checks relative angular movement between clamped ends.

These separate tests matter when a manufacturer wants a claim for a component rather than a whole prosthesis. They also isolate the parts that usually govern failure, such as a foot unit, a knee lock or a flexion stop.

Records, report and marking

Clauses 18 to 21 require a laboratory log, a test report and a classification/designation in the form ISO 10328 - P - R - m kg. The identifier and instructions for use must show the P-level, Test Range and maximum body mass, and the document also gives symbol requirements for the label layout.

For users, this turns the test result into something traceable and markable. For procurement or quality control, the identifier is the quick check that the product was tested for the stated level and intended use.

What terms does kSIST FprEN ISO 10328:2026 define?

• Proof strength - A static load representing an occasional severe event that the prosthetic device/structure can sustain and still function as intended.
• Ultimate strength - A static load representing a gross single event that the prosthetic device/structure can sustain, but which may leave it unusable afterwards.
• Fatigue strength - A cyclic load that the prosthetic device/structure can sustain for a given number of cycles.
• Batch - The set of test samples of a prosthetic device/structure submitted together to a test laboratory/facility.
• Shock absorption capacity - The ability of a specimen to absorb energy by deflection without a proportional increase of force.
• Test Range (R) - The range assigned from the manufacturer’s written intended use and used to select the cyclic loading profile and claim.
• Lower limb prosthetic device/structure - The prosthetic item being tested, including complete structures, partial structures or individual components as covered by the document.

Who uses kSIST FprEN ISO 10328:2026?

Manufacturers and submitters use kSIST FprEN ISO 10328:2026 to choose samples, define the intended use, set the Test Range (R), and prepare the submission document. They also use it to decide how to classify and mark the product.

Test laboratories and test facilities use it to set up the coordinate system, apply the loads, run the static and cyclic procedures, and record the results. Quality and regulatory teams use it to document conformity evidence for lower-limb prosthetic devices/structures and to keep the test record consistent with the claim.

It is relevant to teams working on ankle-foot devices, foot units, knee units, knee locks and associated components, because the document includes separate procedures for those parts. It is also relevant where a product will be identified with a P-level, Test Range and body mass limit on the device, packaging or instructions for use.

What changed in kSIST FprEN ISO 10328:2026 from the previous edition?

The text named in the document states that the loading-rate range for the alternative static ultimate strength test is now normative at 100 N/s to 10 kN/s, replacing the narrower earlier range cited for ISO 10328:2016. It also adds Annex G with loading level P2 for lower-load applications and Annex H with an alternative test geometry based on recent biomechanical studies.

Which standards are used with kSIST FprEN ISO 10328:2026?

• ISO 8549-1 - Provides the vocabulary used for external limb prostheses and external orthoses.
• ISO 22523:2006 - Provides requirements and test methods for external limb prostheses and external orthoses, and is cited in the scope and conformity context.
• ISO 22675:2024 - Provides requirements and test methods for ankle-foot devices and foot units.
• ISO 7000 - Supplies registered graphical symbols used on equipment and in the identifier layout.
• IEC 60417 - Supplies graphical symbols used on equipment and in the identifier layout.
• ISO 15032 - Is cited in the scope as the standard that describes structural testing of hip units.

Annex ZA also links the document to Regulation (EU) 2017/745 and lists the European references used for the cited standards.

What does the kSIST FprEN ISO 10328:2026 document contain?

The document contains definitions of the test geometry, reference planes, reference points, offsets and effective joint centres, supported by figures for right- and left-sided application. It also contains tables of test forces, moments, cycles, sample counts and loading conditions, including the data used for P2 to P8 and the separate ankle-foot tests.

Several procedures are laid out step by step, including the principal static proof test, principal static ultimate strength test, principal cyclic test, separate torsion test, separate ankle-foot and foot-unit tests, and the maximum knee-flexion test. The text also includes flowchart-style figures, equipment requirements, accuracy requirements and guidance on the force-deflection evaluation used for shock absorption capacity.

The annexes add background data, formulas for internal loads and offsets, log-record summaries, and the alternative geometry for guidance. Annex ZA adds the regulatory mapping used in the European context.

SLOVENSKI STANDARD
oSIST prEN ISO 10328:2025
01-september-2025
Protetika - Preskušanje strukture protez spodnjih okončin - Zahteve in preskusne
metode (ISO/DIS 10328:2025)
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test
methods (ISO/DIS 10328:2025)
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen
und Prüfverfahren (ISO/DIS 10328:2025)
Prothèses - Essais portant sur la structure des prothèses de membres inférieurs -
Exigences et méthodes d'essai (ISO/DIS 10328:2025)
Ta slovenski standard je istoveten z: prEN ISO 10328
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 10328:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 10328:2025
oSIST prEN ISO 10328:2025
DRAFT
International
Standard
ISO/DIS 10328
ISO/TC 168
Prosthetics — Structural testing
Secretariat: DIN
of lower-limb prostheses —
Voting begins on:
Requirements and test methods
2025-06-17
Prothèses — Essais portant sur la structure des prothèses de
Voting terminates on:
membres inférieurs — Exigences et méthodes d'essai
2025-09-09
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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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 10328:2025(en)
oSIST prEN ISO 10328:2025
DRAFT
ISO/DIS 10328:2025(en)
International
Standard
ISO/DIS 10328
ISO/TC 168
Prosthetics — Structural testing
Secretariat: DIN
of lower-limb prostheses —
Voting begins on:
Requirements and test methods
Prothèses — Essais portant sur la structure des prothèses de
Voting terminates on:
membres inférieurs — Exigences 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 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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Published in Switzerland Reference number
ISO/DIS 10328:2025(en)
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ISO/DIS 10328:2025(en)
Contents Page
Foreword .vii
Introduction .ix
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols . 2
5 Strength and related performance requirements and conditions of use . 3
6 Coordinate systems and test configurations . 4
6.1 General .4
6.2 Axes of coordinate systems.5
6.3 Reference planes .5
6.3.1 General .5
6.3.2 Top reference plane, T.5
6.3.3 Knee reference plane, K .5
6.3.4 Ankle reference plane, A .5
6.3.5 Bottom reference plane, B . .6
6.4 Reference points.8
6.5 Test force . .8
6.6 Load line .8
6.7 Longitudinal axis of the foot and effective joint centres and centrelines .8
6.7.1 General .8
6.7.2 Longitudinal axis of the foot .8
6.7.3 Effective ankle-joint centre .8
6.7.4 Effective ankle-joint centreline .10
6.7.5 Effective knee-joint centreline . .10
6.7.6 Effective knee-joint centre .11
6.8 Reference distances .11
6.8.1 Offsets .11
6.8.2 Combined offsets . 12
6.8.3 Effective lever arms L and L . 12
A K
6.8.4 Distance L . 12
BT
7 Test loading conditions and test loading levels .12
7.1 Test loading conditions . 12
7.1.1 General . 12
7.1.2 Test loading conditions of principal structural tests . 12
7.1.3 Test loading conditions of separate structural tests . 13
7.2 Test loading levels and Test Ranges (R) . 13
8 Values of test loads, dimensions and cycles . 14
9 Compliance .20
9.1 General . 20
9.2 Selection of tests required to claim compliance with this document . 20
9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot
devices or foot units, required to claim compliance with this document . 20
9.3.1 General . 20
9.3.2 Particular arrangements concerning the ankle-foot device or foot unit . 20
9.3.3 Particular arrangements and requirements concerning the part required to
connect the ankle-foot device or foot unit to the remainder of the prosthetic
structure .21
9.4 Number of tests and test samples required to claim compliance with this document .21
9.5 Multiple use of test samples . .21
9.5.1 General .21

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9.5.2 Restriction . 22
9.6 Testing at particular test loading levels not specified in this document . 22
10 Test samples .24
10.1 Selection of test samples .24
10.1.1 General .24
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot . 25
10.2 Types of test samples . 25
10.2.1 Complete structure . 25
10.2.2 Partial structure . 28
10.2.3 Any other structure . 28
10.3 Preparation of test samples . 28
10.4 Identification of test samples . 29
10.5 Alignment of test samples . 30
10.5.1 Test samples for principal tests and optional separate tests on knee locks . 30
10.5.2 Test samples for separate tests on ankle-foot devices and foot units . 30
10.5.3 Test samples for separate static ultimate strength tests in maximum knee
flexion for knee joints and associated parts . 30
10.6 Worst-case alignment position of test samples .31
11 Responsibility for test preparation .32
12 Test submission document . .33
12.1 General requirements . 33
12.2 Information required for test samples . 34
12.2.1 All test samples . 34
12.2.2 Test samples for tests on ankle-foot devices and foot units . 34
12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for
knee joints and associated parts . 34
12.3 Information required for tests . 34
12.3.1 General . 34
12.3.2 For all tests . 34
12.3.3 For static tests in torsion and on ankle-foot devices and foot units . 35
12.3.4 For static ultimate strength tests . 35
12.3.5 For cyclic tests . 35
12.3.6 For tests in torsion . 35
12.3.7 For tests on ankle-foot devices and foot units . 35
13 Equipment .35
13.1 General . 35
13.2 Equipment for the principal tests specified in 16.2 and 16.3 . 36
13.2.1 End attachments . 36
13.2.2 Jig (optional) . 38
13.2.3 Test equipment . 38
13.3 Equipment for the separate static test in torsion specified in 17.1 . 40
13.3.1 Test equipment . 40
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 . 40
13.4.1 Test equipment . 40
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for
knee joints and associated parts specified in 17.3 . 44
13.5.1 Extension pieces . 44
13.5.2 Test equipment to perform static compression loading – (Compression testing
machine or other equipment) . 44
13.6 Equipment for the optional separate tests on knee locks specified in 17.4 . 44
13.6.1 End attachments . 44
14 Accuracy .44
14.1 General . 44
14.2 Accuracy of equipment .45
14.3 Accuracy of procedure .45
15 Test principles .45

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15.1 General .45
15.2 Static test procedure .45
15.3 Cyclic test procedure . 49
16 Test procedures – Principal structural tests .49
16.1 Test loading requirements . 49
16.1.1 Preparation for test loading . 49
16.1.2 Application of test loading . 50
16.2 Principal static test procedure . .51
16.2.1 Principal static proof test .51
16.2.2 Principal static ultimate strength test . 56
16.3 Principal cyclic test procedure . 58
16.3.1 General requirements . 58
16.3.2 Test method .59
16.3.3 Performance requirements . . 63
16.3.4 Compliance conditions . 63
17 Test procedures — Separate structural tests . 67
17.1 Separate static test in torsion .67
17.1.1 General .67
17.1.2 Purpose of test .67
17.1.3 Test method .67
17.1.4 Performance requirements . . 69
17.1.5 Compliance conditions . 69
17.2 Separate tests on ankle-foot devices and foot units .71
17.2.1 General .71
17.2.2 Purpose of tests .71
17.2.3 Separate static proof test for ankle-foot devices and foot units .71
17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units . 75
17.2.5 Separate cyclic test for ankle-foot devices and foot units . 78
17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and
associated parts . 84
17.3.1 General . 84
17.3.2 Purpose of test . 84
17.3.3 Applicability of the test to specific test samples. 84
17.3.4 Test method . 85
17.3.5 Performance requirement . 86
17.3.6 Compliance conditions . 86
17.4 Separate optional tests on knee locks . 87
17.4.1 General . 87
17.4.2 Purpose of tests . 87
18 Test laboratory/facility log .87
18.1 General requirements . 87
18.2 Specific requirements . 87
19 Test report .87
19.1 General requirements . 87
19.2 Specific requirements . 88
19.3 Options. 88
20 Classification and designation .88
20.1 General . 88
20.2 Examples of classification and designation . 89
21 Compliance with this document .89
21.1 General . 89
21.2 Example of identifier layout . 89
21.3 Identifier placement . 90
Annex A (informative) Description of internal loads and their effects .91

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Annex B (informative) Reference data for the specification of test loading conditions and test
loading levels and Test Ranges (R) of principal cyclic tests .95
Annex C (informative) Guidance on the application of an alternative static ultimate strength
test .99
Annex D (informative) Summary of the records to be entered in the test laboratory/facility log .100
Annex E (informative) Background information on the loading profiles generated by test
equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot
units according to 17.2.5.1 .110
Annex F (informative) Background Data (reduced) of the six-minute walk test for Adults
(see [5]) .112
Annex G (informative) Guidance on the application of an additional test loading level P2 .113
Annex H (informative) Alternative test geometry for loading condition I and II derived from
recent biomechanical studies .118
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .120
Bibliography .123

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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).
ISO draws attention to the possibility that the implementation of this document may involve the use of patent.
ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect
thereof. As of the date of publication of this document, ISO had not received notice of patents which may be
required to implement this document. However, implementers are cautioned that this may not represent the
latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO
shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics.
This third edition cancels and replaces the second edition (ISO 10328:2016), which has been technically
revised.
The main changes are as follows:
— Offsets for P3 and P4 are combined into the test offset for P5 in Table 7 and have been removed from
document. Outward offset at bottom reference plane has been changed from -19 mm to +19 mm to align
with results from modern gait analysis. Outwards offsets knee and ankle have been adjusted accordingly.
— Test load levels P6 through P8 previously in former Annex D have been included in Tables 5, 9 and 12 and
the Annex removed from the document. Former Annex E and F have been renamed to Annex D and E and
references updated. Former Annex G has been removed. New Annex F, Annex G, Annex H and Annex ZA
have been added.
— Test Ranges (R) for the strength test have been introduced, related to the intended use of the device. The
ranges differ by different loading factors, while tests load levels remain unchanged apart from rounding
and accommodation to changed offsets (see below).
— Test forces in Table 12 have been adjusted for P3 and P4.
— A method to analyse shock absorption capacity has been added, which eliminates the difficulty to decide
whether a device passes or fails above the ultimate static lower load level.
— Separate tests on knee locks are now optional tests and the test methods on separate tests on knee locks
have been removed from the document.
— Test geometry of this document is limited to 150mm above knee-joint centre.
— Section 21 has been renamed to Compliance to Standard and reference to Labelling has been removed
from the document.
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— Table 2, Table 5, Table 6, Table 7, Table 8, Table 9, Table 10, Table 11 and Table 12 have been updated and
forces adjusted for new unified offsets.
— Table B.1, Table B.2, Table B.3 and Table B.4 have been updated.
— The rate of loading of between 100 N/s and 10 kN/s is now normative.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

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Introduction
Throughout this document, the term prosthesis means an externally applied device used to replace wholly,
or in part, an absent limb segment.
As a result of concern in the international community about the need to provide prostheses that are safe in
use, and also because of an awareness that test standards would assist the development of better prostheses,
a series of meetings was held under the aegis of the International Society for Prosthetics and Orthotics
(ISPO). The final one was held in Philadelphia, PA, USA in 1977 at which a preliminary consensus was
reached on methods of testing and the required load values. From 1979 onwards this work was continued by
ISO Technical Committee 168 leading to the development of ISO 10328:1996. The test procedures may not be
applicable to prostheses of mechanical characteristics different from those used in the consensus.
During use, a prosthesis is subjected to a series of load actions, each varying individually with time. The test
methods specified in this document use static and cyclic strength tests which typically produce compound
loadings by the application of a single test force.
The static tests relate to the worst loads generated in any activity. The cyclic tests relate to normal walking
activities where loads occur regularly with each step. This document specifies fatigue testing of structural
components. The tests specified do not provide sufficient data to predict actual service life.
The evaluation of lower-limb prostheses and their components requires controlled field trials in addition to
the laboratory tests specified in this document.
The laboratory tests and field trials should be repeated when significant design changes are made to a load-
bearing part of a prosthesis.
Ideally, additional laboratory tests should be carried out to deal with function, wear and tear, new material
developments, environmental influences and user activities as part of the evaluation procedure. There are
no standards for such tests, so appropriate procedures will need to be determined.

ix
oSIST prEN ISO 10328:2025
oSIST prEN ISO 10328:2025
DRAFT International Standard ISO/DIS 10328:2025(en)
Prosthetics — Structural testing of lower-limb prostheses —
Requirements and test methods
1 Scope
WARNING — This document is not suitable to serve as a guide for the selection of a specific lower
limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any
disregard of this warning can result in a safety risk for amputees.
This document specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE
2) which typically produce compound loadings by the application of a single test force. The compound loads
in the test sample relate to the peak values of the components of loading which normally occur at different
instants during the stance phase of walking.
This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to
the intended use. According to the concept of the tests of this document, each sample of lower limb prosthetic
device / structure submitted for test is, nevertheless, free to develop its individual performance under load.
The tests desc
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