EN ISO 22675:2006

SLOVENSKI STANDARD
01-december-2006
Protetika - Preskušanje mehanizmov za gleženj in stopalo ter enot za stopalo -
Zahteve in preskusne metode (ISO 22675:2006)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test
methods (ISO 22675:2006)
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und
Prüfverfahren (ISO 22675:2006)
Protheses - Essais d'articulations cheville-pied et unités de pied - Exigences et
méthodes d'essai (ISO 22675:2006)
Ta slovenski standard je istoveten z: EN ISO 22675:2006
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.

EUROPEAN STANDARD
EN ISO 22675
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.040.40
English Version
Prosthetics - Testing of ankle-foot devices and foot units -
Requirements and test methods (ISO 22675:2006)
Prothèses - Essais d'articulations cheville-pied et unités de Prothetik - Prüfung von Knöchel-Fuß-Passteilen und
pied - Exigences et méthodes d'essai (ISO 22675:2006) Fußeinheiten - Anforderungen und Prüfverfahren (ISO
22675:2006)
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.
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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 22675:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 22675:2006) 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 22675:2006 has been approved by CEN as EN ISO 22675:2006 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 CEN by the European
Commission and the European Free Trade Association and supports corresponding essential
requirements of EU Directive 93/42/EEC concerning medical devices.

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

The following clauses of this standard are likely to support requirements of Directive 93/42/EEC
concerning medical devices: 5, 6, 7, 8, 9, 10, 15, 16, 17, 20 and 21 (see Table ZA.1).

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

Table ZA.1 — Correspondence between this European Standard and EU Directives

Corresponding Essential Comments
Clauses of this European
Requirements of Directive
Standard
93/42/EEC
5; 6; 7; 8; 9; 10; 15; 16; 17 2, 4, 12.7.1
5; 20; 21 9.1
5; 20; 21 13.1 Essential requirement 13.1 is not fully
covered here; only the aspects of
classification are addressed.
20 13.3 k)
INTERNATIONAL ISO
STANDARD 22675
First edition
2006-10-01
Prosthetics — Testing of ankle-foot
devices and foot units — Requirements
and test methods
Prothèses — Essais d'articulations cheville-pied et unités de pied —
Exigences et méthodes d'essai
Reference number
ISO 22675:2006(E)
©
ISO 2006
ISO 22675:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 22675:2006(E)
Contents Page
Foreword. vii
Introduction . viii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Designations and symbols of test forces . 2
5 Strength and related performance requirements and conditions of use. 3
6 Coordinate system and test configurations . 4
6.1 General. 4
6.2 Origin and axes of the coordinate system . 4
6.3 Reference points. 5
6.4 Test force F. 6
6.5 Line of application of test force F . 6
6.6 Lines of action of resultant reference forces F and F . 6
R1 R2
6.7 Longitudinal axis of the foot and effective ankle joint centre. 6
6.7.1 General. 6
6.7.2 Longitudinal axis of the foot. 6
6.7.3 Effective ankle-joint centre, C . 7
A
7 Test loading conditions and test loading levels. 8
7.1 Test loading conditions. 8
7.2 Test loading levels. 8
8 Values of test forces, dimensions and cycles . 9
9 Compliance. 16
9.1 General. 16
9.2 Particular arrangements and requirements concerning the part required to connect an
ankle-foot device or foot unit to the remainder of a prosthetic structure . 17
9.2.1 Arrangements for testing. 17
9.2.2 Requirements for claiming compliance.17
9.3 Number of tests and test samples required to claim compliance with this International
Standard . 17
9.4 Multiple use of test samples. 18
9.4.1 General. 18
9.4.2 Restriction . 18
9.5 Testing at particular test loading levels not specified in this International Standard. 18
10 Test samples . 19
10.1 Selection of test samples. 19
10.1.1 General. 19
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot. 19
10.2 Types of test sample . 20
10.2.1 Complete structure. 20
10.2.2 Partial structure . 20
10.3 Preparation of test samples. 20
10.4 Identification of test samples . 21
10.5 Alignment of test samples . 21
10.6 Worst-case alignment position of test samples . 21
11 Responsibility for test preparation . 23
12 Test submission document . 24
12.1 General requirements. 24
12.2 Information required for test samples. 24
12.3 Information required for tests . 25
12.3.1 General. 25
12.3.2 For all tests. 25
12.3.3 For the static proof test and the static ultimate strength test . 25
ISO 22675:2006(E)
12.3.4 For the static ultimate strength test. 25
12.3.5 For the cyclic test. 25
13 Equipment. 26
13.1 General . 26
13.2 End attachments . 26
13.2.1 General . 26
13.2.2 Proof test of end attachments . 26
13.3 Jig (optional). 28
13.4 Test equipment. 28
13.4.1 Test equipment to perform static heel and forefoot loading. 28
13.4.2 Test equipment to perform cyclic loading.30
14 Accuracy . 37
14.1 General . 37
14.2 Accuracy of equipment . 37
14.3 Accuracy of procedure . 38
15 Test principles. 38
15.1 General . 38
15.2 Static test procedure . 39
15.3 Cyclic test procedure. 39
16 Test procedures . 39
16.1 Test loading requirements . 39
16.1.1 Preparation for test loading . 39
16.1.2 Test loading conditions. 43
16.2 Static proof test. 43
16.2.1 Test method. 43
16.2.2 Performance requirement . 45
16.2.3 Compliance conditions. 45
16.3 Static ultimate strength test. 47
16.3.1 Test method. 47
16.3.2 Performance requirements . 50
16.3.3 Compliance conditions. 50
16.4 Cyclic test . 52
16.4.1 Test method. 52
16.4.2 Performance requirements . 54
16.4.3 Compliance conditions. 55
17 Test laboratory/facility log . 58
17.1 General requirements . 58
17.2 Specific requirements. 58
18 Test report. 58
18.1 General requirements . 58
18.2 Specific requirements. 59
18.3 Options. 59
19 Classification and designation . 59
19.1 General . 59
19.2 Examples of classification and designation . 59
20 Labelling. 60
20.1 General . 60
20.2 Use of mark "*)" and warning symbol. 61
20.3 Examples of label layout . 61
20.4 Label placement . 62
Annex A (informative) Reference data for the specification of the test loading conditions and test
loading levels of this International Standard .63
Annex B (informative) Guidance on the application of an alternative static ultimate strength test . 71
Annex C (informative) Guidance on the application of an additional test loading level P6. 72
Annex D (informative) Summary of the records to be entered in the test laboratory/facility log . 74
[1]
Annex E (informative) Information on Technical Report ISO/TR 22676 . 80
Annex F (informative) Reference to the essential principles of safety and performance of medical
devices according to ISO/TR 16142 . 91
Bibliography . 92

iv © ISO 2006 – All rights reserved

ISO 22675:2006(E)
Figure 1 — Coordinate system with reference parameters. 5
Figure 2 — Determination of longitudinal axis of foot (see 6.7.2) and effective ankle-joint centre
C (see 6.7.3) . 7
A
Figure 3 — Illustration of reference points for the establishment of thresholds listed in Table 10
for specification of the loading profile of the cyclic test. 14
Figure 4 — Illustration of specific set-up of left-sided test sample with top load application
point P . 23
T
Figure 5 — Diagrammatic view of test equipment according to 13.4.1 and 13.4.2 with test sample. 35
Figure 6 — Profiles of test force F (t) and tilting angle γ(t) as synchronized functions of time,
c
determining the loading condition of the cyclic test of this International Standard . 36
Figure 7 — Test force F (γ) of test loading level P5 as function of tilting angle γ(t) of foot platform. 37
c
Figure 8 — Preparation for test loading of static test procedure [see 16.1.1 a)] . 42
Figure 9 — Flowchart for the static proof test specified in 16.2.1.46
Figure 10 — Flowchart for the static ultimate strength test specified in 16.3.1. 51
Figure 11 — Flowchart for the cyclic test specified in 16.4.1 Continued on Figure 12. 56
Figure 12 — Flowchart for the cyclic test specified in 16.4.1 Continued from Figure 11 . 57
Figure 13 — General concept for the label layout. 60
Figure 14 — Models for the label layout. 61
Figure A.1 — Illustration of different components of loading. 69
Figure A.2 — Illustration of the dependence of the position of the top load application point P on
T
the foot length L — (see A.2.2.3). 70
Figure E.1 — Effect of f-position of tilting axis TA of foot platform on the elevation E of the foot at
the instants of heel contact and toe-off. 83
Figure E.2 — Effect of u-position of tilting axis TA of foot platform on the A/P displacement ∆f of
the foot at the instant of toe-off. 84
Figure E.3 — Illustration of the effect of A-P displacement ∆f on the angular movement ∆ϕ
of the test sample about the top load application point P . 85
T
Figure E.4 — Illustration of possibilities of transposing the top load application point P
T
for compensation of the dependence of the position of the tilting axis TA of the foot
platform on the foot length L . 88
Figure E.5 — Illustration of the effect of a fixed compromise offset u of the tilting axis TA
TA, C
of the foot platform on the A-P displacement ∆f at the foot [see E.3.4.2 c) 2)] . 89

Table 1 — Designations and symbols of test forces . 2
Table 2 — Categories of strength addressed in this International Standard, together with the
related performance requirements and test methods for their verification . 3
Table 3 — Test forces and relevant references . 9
Table 4 — Values of bottom offsets f (heel) and f (forefoot) for given values of foot length
B1, L B2, L
L, relevant to the design and/or adjustment of the rigid foot dummy required to simulate
the effective lever arms of an ankle-foot device or foot unit in the proof test of end
attachments (see 13.2.2) . 10
Table 5 — Test forces of the proof test of end attachments for test loading levels P5, P4 and P3
(see 13.2.1). 10
ISO 22675:2006(E)
Table 6 — Total length of test samples and segmental lengths of end attachments. 11
Table 7 — Coordinates of top load application point P and tilting axis TA of foot platform based
T
on given values of foot length L, for all test loading levels. 12
Table 8 — Angles of toe-out position of foot and specific tilting positions of foot platform, for all
test loading levels . 12
Table 9 — Test forces for all tests and prescribed number of cycles for the cyclic test, for test
loading levels P5, P4 and P3 (see 16.2, 16.3 and 16.4). 13
Table 10 — Thresholds according to Figure 3 for specification of the application of the loading
profile of the cyclic test . 15
Table 11 — Data specifying the values of tilting angle γ(t) and test force F (t) illustrated in
c
Figure 6 in 30 ms time increments for guidance on their application. 16
Table 12 — Number of tests and test samples required to claim compliance with this
International Standard . 19
Table 13 — Option for end attachments of specific design .26
Table A.1 — Magnitudes of resultant reference forces F and F . 66
R1x R2x
Table C.1 — Test forces of the proof test of end attachments for test loading level P6
(see 13.2.2.1) . 72
Table C.2 — Test forces for all tests and prescribed number of cycles for the cyclic test,
for test loading level P6 (see 16.2, 16.3 and 16.4) . 73
Table E.1 — Contents of ISO/TR 22676 and list of corresponding clauses/subclauses of this
International Standard, in which selected items are dealt with . 81
Table E.2 — Possibilities of transposing the top load application point P for compensation of
T
the dependence of the position of the tilting axis TA of the foot platform on the foot
length L. 90
Table F.1 — Correspondence between this International Standard and the essential principles of
ISO/TR 16142 . 91

vi © ISO 2006 – All rights reserved

ISO 22675:2006(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 22675 was prepared by Technical Committee ISO/TC 168, Prosthetics and orthotics.
ISO 22675:2006(E)
Introduction
This International Standard offers alternatives to the structural tests on ankle-foot devices and foot units
specified in 17.2 of ISO 10328:2006, which still suffer from several “weaknesses”, such as:
a) the inconsistency of the lines of application of the heel and forefoot test forces with those of the test forces
of test loading conditions I and II for the principal structural tests specified in 16.2 (static tests) and 16.3
(cyclic test) of ISO 10328:2006;
b) the unrealistic course and magnitude of loading in the phase between the instants of maximum heel and
forefoot loading during the cyclic test;
c) the effect of periodical “stepping in a hollow” during the cyclic test, resulting from simultaneous heel and
forefoot loading at different angles.
In this relation it is important to note that the complexity of the test equipment required for the testing of ankle-
foot devices and foot units specified in this International Standard is low, comparable to that of the test
equipment required for the corresponding separate structural tests specified in ISO 10328. Apparently, basic
components of both types of test equipment are similar and can be re-used in a modified design.
Finally, it has to be noted that the potential of the general concept applied to the test procedures specified in
this International Standard allows other applications directed to the assessment of specific performance
characteristics of ankle-foot devices and foot units that may be of relevance in the future.
In order to allow continuity of testing by checking the test methods for ankle-foot devices and foot units
specified in this International Standard against those specified in 17.2 of ISO 10328:2006, 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 10328:2006 and this International
Standard 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 this International Standard have demonstrated their
suitability.
NOTE Further guidance on the specification of the test loading conditions and test loading levels and on the design
of appropriate test equipment is given in a separate document, published as a Technical Report (see Bibliography).

viii © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 22675:2006(E)

Prosthetics — Testing of ankle-foot devices and foot units —
Requirements and test methods
1 Scope
IMPORTANT — This International Standard is suitable for the assessment of the conformity of
prosthetic ankle-foot devices and foot units 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 EN 12523:1999
through submission to the relevant tests of ISO 10328:1996, need not be retested to this International
Standard.
WARNING — This International Standard is not suitable to serve as a guide for the selection of a
specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any
disregard of this warning can result in a safety risk for amputees.
This International Standard primarily specifies a cyclic test procedure for ankle-foot devices and foot units of
external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions
of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of
performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs
of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions
of loading.
In addition, this International Standard specifies a static test procedure for prosthetic ankle-foot devices and
foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other
features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to
those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
The loading conditions addressed in the third paragraph are characterized by a loading profile determined by
the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile
determined by the tibia angle.
The test loading conditions specified in this International Standard are characterized by standardized formats
of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to
each sample of ankle-foot device or foot unit submitted for test.
According to the concept of the tests of this International Standard, each sample of ankle-foot device or foot
unit submitted for test is, nevertheless, free to develop its individual performance under load.
NOTE 1 ISO 22523 (formerly EN 12523) addresses those of the Essential Requirements listed in Annex I of the
European Medical Device Directive 93/42/EEC that are applicable to external limb prostheses and external orthoses.
NOTE 2 The lines of action of the heel and forefoot forces generated by the static test procedure specified in this
International Standard approach those determining the sagittal plane loading of the test loading conditions I and II for the
principal structural tests specified in ISO 10328, without changing the values of the angles of the heel and forefoot
platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328.

ISO 22675:2006(E)
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 8549-1, Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses
and external orthoses
ISO 10328:2006, Prosthetics — Structural testing of lower limb prostheses — Requirements and test methods
ISO 22523:2006, External limb prostheses and external orthoses — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8549-1 and the following apply.
3.1
proof strength
static load representing an occasional severe event, which can be sustained by the ankle-foot device or foot
unit and still allow it to function as intended
3.2
ultimate strength
static load representing a gross single event, which can be sustained by the ankle-foot device or foot unit but
which could render it thereafter unusable
3.3
fatigue strength
cyclic load that can be sustained by the ankle-foot device or foot unit for a given number of cycles
3.4
batch
set of test samples of an ankle-foot device or foot unit submitted together to a test laboratory/facility to
undertake tests to demonstrate compliance with one or more requirements of this International Standard
4 Designations and symbols of test forces
The designations and symbols of all relevant test forces are listed in Table 1.
Table 1 — Designations and symbols of test forces
Designation Symbol
Test forces
F, F , F
1 2
Settling test force F
set
Stabilizing test force F
stab
Proof test force of end attachments F

pa
Static proof test force on heel/forefoot F , F
1sp 2sp
Static ultimate test force on heel/forefoot F , F
1su 2su
Pulsating test force F (t); F (γ)
c c
1st and 2nd maximum value of pulsating test force F , F
1cmax 2cmax
Intermediate minimum value of pulsating test force F
cmin
Final static test force on heel/forefoot F , F
1fin 2fin
NOTE Further details of the test forces listed are given in Table 3.
2 © ISO 2006 – All rights reserved

ISO 22675:2006(E)
5 Strength and related performance requirements and conditions of use
5.1 According to 4.4.1 of ISO 22523:2006, a prosthetic ankle-foot device or foot unit “… shall have the
strength to sustain the loads occurring during use by amputees […] in the manner intended by the
manufacturer for that device according to his written instructions on its intended use”.
For the assessment of the conformity of ankle-foot devices and foot units with the above requirement
(see also Scope), this International Standard provides means of determining different categories of strength.
These are defined in 3.1 to 3.3 and listed in Table 2, together with the related performance requirements and
the test methods for their verification.
5.2 In order to satisfy the general requirement in 5.1 for a specific ankle-foot device or foot unit, the
following safety concept shall apply:
The device shall
a) comply with the requirements of this International Standard (see 9.1 and 9.2) for a specific test loading
level (see 7.2)
and
b) be used in accordance with the body mass limit specified by the manufacturer in consideration of the
intended use of that device (see NOTE).
The conditions in a) and b) are regarded in both the classification and designation of ankle-foot devices and
foot units according to Clause 19 and their labelling according to Clause 20.
NOTE The statement of the body mass limit not to be exceeded by amputees is part of the conditions of use to be
specified, with justification, by the manufacturer in his written instructions on the intended use of a specific ankle-foot
device or foot unit, taking account of all other factors affecting the loads expected to be exerted on that ankle-foot device
or foot unit by amputees (see Clause A.1).
Table 2 — Categories of strength addressed in this International Standard,
together with the related performance requirements and test methods for their verification

a
Category of strength Related performance requirement Test method for verification
Structure shall sustain static loading by the proof
Static proof test (16.2.1), successively
Proof strength (see 3.1) test forces F and F at the prescribed
1sp 2sp
applying heel and forefoot loading.
values for the prescribed time (see 16.2.2).
Structure shall sustain static loading by the Static ultimate strength test (16.3.1),
Ultimate strength (see 3.2) ultimate test forces F and F at the separately applying heel and forefoot
1su 2su
prescribed values (see 16.3.2). loading.
Structure shall sustain successively (see 16.4.2)
Cycli
...