INTERNATIONAL

STANDARD

First edition
2006-10-01

Prosthetics - Testing of ankle-foot

devices and foot units - Requirements
and test methods
Protheses - Essais d'articulations cheville-pied et unites de pied -
Exigences et rnethodes d'essai

T l S l Library
~ ~ r n y m u i r s j i u

Thai Industrial Standards Institute : TlSl

Rama vl Rd., Rajathevee Bangkok 10400 Tel : 202-3510 1
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IS0 22675:2006(E)
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Contents Page

Foreword VI
..
...........................................................................................................................................................
Introduction VII
...
....................................................................................................................................................
1 Scope .....................................................................................................................................................
I
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 referenceforces FR1and Fw ...............................................................
6
6.7 .
Lonaitudinal 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 anklejoint centre. CA ............................................................................................................
7
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
Arrangements for testing ...................................................................................................................
17
Requirements for claiming compliance ............................................................................................
17
Number of tests and test samples required to claim compliance with this International
Standard ..............................................................................................................................................
17
Multiple use of test samples ..............................................................................................................
18
General .................................................................................................................................................
18
Restriction ...........................................................................................................................................
18
Testing at particular test loading levels not specified in this International Standard 18 .................
Test samples .......................................................................................................................................
19
Selection of test samples .................................................................................................................
49
General ..............................................................................................................................................
19
Selection of ankle-foot devices and foot units of appropriate size of foot ...................................
19
Types of test sample ........................................................................................................................
20
Complete structure .............................................................................................................................
20
Partial structure ..................................................................................................................................
20
Preparation of test samples ...............................................................................................................
20
Identificationof test samples ............................................................................................................
21
Alignment of test samples .................................................................................................................
21
Worst-case alignment position of test samples ..............................................................................
21
Responsibility for test preparation ................................................................................................
23
Test submission document ..............................................................................................................
24
General requirements ......................................................................................................................
24
Informationrequiredfor test samples ..............................................................................................
24
Information required for tests ...........................................................................................................
25
General .................................................................................................................................................
25
For all tests ..........................................................................................................................................
25
For the static proof test and the static ultimate strength test .......................................................
25

8 IS0 2006 -All rights reserved iii

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 laboratorylfacility 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 6 (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 laboratorylfacility log 74 ............
Annex E (informative) Information on Technical Report ISOKR 22676 ['I ..................................................
80
Annex F (informative) Reference to the essential principles of safety and performance of medical
devices according to ISOrrR 16142 ..................................................................................................
91
BibliOgmphy .................................................................................................................................................
92

Q IS0 2006 -All rights reserved

 Figure I-- Coordinate system with reference parameters ...........................................................................5
Figure 2 .Determination of longitudinal axis of foot (see 6.7.2) and effective anklejoint centre
CA (see 6.7.3) ..................................................................................................................................7
Figure 3 . lllustration 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 . lllustration of specific set-up of left-sided test sample with top load application
point PT ................................................................................................................................................23
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 At) as synchronized functions of time.
determining the loading condition of the cyclic test of this International Standard ...................36
Figure 7 -Test force F,(d of test loading level P5 as function of tilting angle At) of foot platform...... 37
Figure 8 -- Preparation for test loading of static test procedure [see 16.1.1 a)] ......................................42
...........................................................46
Figure 9 -- Flowchart for the static proof test specified in 16.2.1
Qb Figure 10 -- Flowchart for the static ultimate strength test specitied 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 1 1 ........................... 57
--

Figure 13 -- General concept for the label layout........................................................................................60

F i g u w l 4 Models for the label layout....................................................................................................61
--

Figure A.1 -- Illustration of different components of loading..................................................................... 69

Figure A.2 . lllustration of the dependence of the position of the top load application point PT on
the foot length L -- (see A.2.2.3) ........................................................................................................70
Figure E.l . 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 AIP displacement Afof
the foot at the instant of toeoff ......................................................................................................... 84
Figure E.3 .
lllustration of the effect of A-P displacement Afon the angular movement Ay,
of the test sample about the top load application point PT ..........................................................85
Figure E.4 . lllustration of possibilities of transposing the top load application point PT
c) 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 .
lllustration of the effect of a fixed compromise offset *A, of the tilting axis TA
of the foot platform on the A-P displacement Af at the foot [see E.3.4.2 c) 2)] .............................89

Table I-- 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
able 4 -.Values of bottom offsetsfB19 (heel) andfB2 (forefoot) for given values of foot length
L. relevant to the design andlor adjustment of k 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

Q IS0 2006 .All rights reserved v

Table 6 -Total length of test samples and segmental lengths of end attachments............................... I 1
Table 7 - Coordinates of top load application point PTand tilting axis TA of foot platform based
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 t o Figure 3 for specification of the application of the loading
profile of the cyclic test ............................................................................................................... I 5
-
Table 11 Data specifying the values of tilting angle At) and test force F,(t) illustrated i n
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 FRlxand FR2........................................................ 66
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.l- Contents of ISOrrR 22676 and list of corresponding clauseslsubclauses of this i)
International Standard, in which selected items are dealt with ...............................................81
Table E.2 - Possibilities of transposing the top load application point Pi for compensation of
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
lSO/TR 16142 ....................................................................................................................................... 91

8 IS0 2006 -All lights resenred

 Foreword
IS0 (the lnternational Organization for Standardization) is a worldwide federation of national standards bodies
(IS0 member bodies). The work of preparing lnternational Standards is normally carried out through IS0
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. lnternational organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. IS0 collaborates closely with the
lnternational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

lnternational Standards are drafted in accordance with the rules given in the ISOllEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft lnternational Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an

8 lnternational 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. IS0 shall not be held responsible for identifying any or all such patent rights.

IS0 22675 was prepared by Technical Committee ISOrrC 168, Prosthetics and ofthotics.

8 IS0 2006 -All rights resenred

Introduction
This lnternational Standard offers alternatives to the structural tests on ankle-foot devices and foot units
specified in 17.2 of IS0 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 IS0 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 lnternational Standard is low, comparable to that of the test
equipment required for the corresponding separate structural tests specified in IS0 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 lnternational 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 lnternational Standard against those specified in 17.2 of IS0 10328:2006, a transition period
win be established, during which &&I test methods are valid. For practical reasons, this transition period will
be adapted to the period of time after which the systematic review of IS0 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 lnternational 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
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I S 0 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.
IS0 8549-1, Prosthetics and orthotics - Vocabulary- Part 1: General terms for external limb prostheses
and external orthoses
IS0 10328:2006, Prosthetics - Structural testing of lower limb prostheses -Requirements and test methods
IS0 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 IS0 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 IaboratoryRacili 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 - Designationsand symbols of test forces

Proof test force of end attachments

urn value of pulsating test force

rn~nlrnum value of pulsating test force
Final static test force on heeWorefoot
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q ( C.Eaas) qflua~wj o o ~ d
AlaAlsswns '(L'Z'9L) jWd load at8 Aq 6u!peol 3 j q s u!qsns lleqs arnpnyS
uwmylrerr JOJ pow= )sei ,auau~arinbwe w w u o ~ l a dmepl( w 6 u q s 40 h o m e 3
u o g m y y e J~ p w JOJ spoy)etu pqpue quewwlnbw e~ueuuoyedm e l a ew w.m ~ewefka
'wepurrls ieuoneuelui s!w u! pesseJppe wf3uws 40 seuoWe3 z eiqel -
'(c'v asnel3 aas) smndwe Aq gun too/ JO
q a p loqialyue ww uo pavaxa aq 01 p a m a speol a q ~ Gu!palle sopel JWO I I 40~ 1un- &!ye1 'gun 10% JO =!w
tooj-awue w a d s e jo asn papualu! aql uo suo!pqsu! u a w s!q u! Janpqnuew atu Aq 'uo!tmy!tsn! g ! 'paypads
~
aq 01 asn jo suo~~!pucx,
aqt jo ved s! saawdwe Aq pap-xa aq 01 )ou )!w!l ssew Apoq aqljo 1uawa)e)s a u 310~
'OZ asnel=) 01 6ulpJ033e 6u!llaqel J!aqj pue 61 asnet=) 01 6u!p~<meq!un loo4
pue sa!r\ap loo4-alyue 40 uo!leu6!sap pue uo!leqgssep aql W u! papJe6aJ ale (q pue (e u! suo!gpua a q l
' ( 3 1 0 ~aas) aqnap )eq)jo asn papuaju!
aql 40 uo!)wap!suoa u! JaJnpeJnuew aqt Aq payaads )!lu!(sselu Apoq a q q l p ~auepJmae u! pasn aq (q
(Z'L ass) l a w
6
6u!peo1lsal aypads e JOJ (2.6 pue ~ ' aas) pJepue)S leuo!)euJalul s!ql4o slualua~!nba~
aql q ~ Aldwoa
p ~ (e
'uo!leayua~J!aql JOJ spoqaw Isa) aqt
pue stuawa~!nba~ aaueuuoyad pa)elaJ aq) q l p ~
~aqta60)'Z alqel u! pa)s!l pue c.c 01 ~ . u!
c pauyap aJe asaql
J ~
'ql6uaJls 40 sa!~o6a)m:,uaJag!p 6u!u!uua)ap 40 suealu S ~ ~ ! A OpJepuQS leuo!leuJa)ul s!q) '(adoas osle aas)
lualua~!nba~ aAoqe aql qpw sl!un $00~pue sa!Aap poi-alyue 40 &uuo~um aql 40 lualussasse a* ~ o j
S U ! s!y oj 6u!p~033ew n a p jeuj JOJ ~anj3ejnuew
',,asnpapuaju! s# uo S U O I I ~ N ~uaNm
auj Aq pepuaju! Jeuueur eyj u! [ - - I saa)ndure Aq asn 6u!~np6u.unxm speol ayj u!ejsns o) y @ u ~ s
ayj aney Ileys )!un 1004 JO aa!~aploo4-alyue a!)aqlso~de '900z:Ez9zZ OSI 40 lL'P'Pol ~ ~ ! P J O ~ VC's
"'.
asn 40 suo!~puo3pue quaurarpba~aaueuuogad paJelar pule q~6uarJg s
(3)900z:s~9zzOSI
6 Coordinate system and test configurations

6.1 General
The test configurations of this International Standard are defined in a manner similar to that applied in
IS0 10328.

Each test configuration shall be defined in a two-dimensional, rectangular coordinate system (see Figure 1).

Each test configuration specifies reference parameters both for the position of the line of application of the test
force and for the alignment of test samples within the coordinate system.

6.2 Origin and axes of the coordinate system

The origin and the axes of the coordinate system are specified in a) to c) in relation to a prosthesis which is
standing on the ground in an upright position. In Figure 1 the ground is represented by the bottom plane B.

If a test sample is not in the vertical position, the axes of the coordinate system shall be rotated to correspond.
b
a) The origin 0 of the coordinate system is located in the bottom plane B.

b) The u-axis extends from the origin 0 perpendicular to the bottom plane B and passes through the effective
ankle-joint centre CA, specified in 6.7.3 (see Figure 1). Its positive direction is upwards (in the proximal
direction).

NOTE The u-axis also passes through the effective kneejoint centre CK (see Figure 1). This may be relevant to
the setting-up of test samples of specific designs of ankle-foot devices or foot units which extend towards the knee
unit of a lower limb prosthesis and which, therefore, may also requite the knowledge of the position of the effective
knee joint centre.

c) The faxis extends from the origin 0 perpendicular to the u-axis (see Figure 1). Its positive direction is
forward towards the toe (in the anterior direction).

A l l rights resenred
 bottom plane (see 6.2)
origin of coordinate system [see 6.2 a)]
(upward) axis of coordinate system [see 6.2 b)]
(forward) axis of coordinate system [see 6.2 c)]
effective ankle-joint centre [see 6.2 b) and 6.7.31
effective kneejoint centre [see NOTE of 6.2 b)]
top load application point (see 6.3)
knee load reference points (see 6.3)
ankle load reference points (see 6.3)
bottom load application points (see 6.3)
line of application of test force F (see 6.5)
line of action of resultant reference force FR1(heel loading) (see 6.6)
line of action of resultant reference force FR2(forefoot loading) (see 6.6)

Figure 1 -Coordinate system with reference parameters

6.3 Reference points

The reference points determine the position of the line of application of the test force F (see 6.5) and the lines
of action of the resultant reference forces FRi (heel loading) and FW (forefoot loading) (see 6.6 and
Figure A.1) within the f-rplane of the coordinate system (see 6.2 and Figure 1). The coordinates of the
reference points are as follows:
- top load application point (see NOTE I), PT6, uT);

- knee load reference point, PK Vi<, UK)

- ankle load reference point (see NOTE 2), PA (rA,uA);

- bottom load application point, P~ VB, 0)

The only reference point to be defined and specified for the application of the test principles outlined in 15.1 is
the top load application point PT, at which the test force F (see 6.4) is applied to the test sample (see Fgure I).

Q IS0 2006 -All rights reserved

The reference points at knee, ankle and bottom level are required to specify the lines of action of the resultant
reference forces FR, and FR2.

IMPORTANT - In the subsequent clauses of this International Standard, the f-coordinates are also
referred to as OFFSETS.

NOTE 1 If appropriate, the dependence of the position of the top load application point PT VT,uT) On the foot length L is
indicated by the additional suffix 'C in the form PT VT,L, uT,L) (see 10.5, 16.1.l , A.2.2.3, A.2.4.1, E.3.4.2, Figures 4 and 5
and Table 7). If appropriate, general suffix 'C may be replaced by speafic values (see Figures A.2 and E.4).

NOTE 2 If the ankle load reference point PA (rA, uA)describes the position of specific lines of action as illustrated in
Figure 1 for heel loading by resultant reference fore FRi and forefoot loading by resultant reference force F,, this may
be indicated by the additional suffixes '1' for heel loading and '2' for forefoot loading in the form PA, VA,,u,,) or
P, &, u,), if appropriate (see A.2.2). The additional suffixes '1' and '2' are also used to identify the fB-o%ets addressed
in 13.2.2.2.1 and listed in Table 4.

6.4 Test force F

The test force F is a single load applied to the top load application point PT specified in 6.3 along its line of
application specified in 6.5.

NOTE During testing, a force component, FH, perpendicular to the line of application of the test force F develops as
shown in Figure A. 1 on the test machine.

6.5 Line of application of test force F

The line of application of the test force F passes through the top load application point PT parallel to the u-axis
(see Figures 1, 5 and A. 1).

6.6 Lines of action of resultant reference forces FRl and FR2

The lines of action of the resultant reference forces FR1and Fw (see Figure A.l) pass through the reference
points specified in 6.3, intersecting at the top load application point PT [see also 15.1 d)]. They determine the
directions of static and maximum cyclic heel and forefoot reference loading (see A.2.2).

NOTE For further background informationsee also A.2.4.

6.7 Longitudinal axis of the foot and effective ankleloint centre

6.7.1 General

In order to align the test sample within the coordinate system (see 6.1 and 6.2) it is necessary to locate
a) the longitudinal axis of the foot (see 6.7.2);

b) the effective ankle-joint centre (see 6.7.3).

If the lacation of the longitudinal axis of the foot or the effective ankle-joint centre is not straightforward, the
manufacturerlsubmitter shall provide a diagram or instructions, with justification, identifying its location in
relation to the test sample.

6.7.2 Longitudinal axis of the foot

Unless otherwise specified by the manufacturer/submiier, the longitudinal axis of the foot shall be taken to
pass through the centre of the widest part of the forefoot and equidistant between the medial and lateral
bo&rs of the foot at a quarter of the length of the foot from the most posterior part of the foot with the foot
placed as specified in 6.7.3.3 and illustrated in Figure 2.

Q IS0 2006 -All rights reserved

6.7.3 Effective ankle-joint centre, CA

6.7.3.1 Locate the effective ankle-joint centre CA as described in 6.7.3.2 to 6.7.3.4.

NOTE The position of a mechanical axle for plantar- and dorsiflexion (if present) is irrelevant to the alignment of the
test sample within the coordinate system.
6.7.3.2 Locate the longitudinal axis of the foot as described in 6.7.2 or in accordance with any specific
instruction from the manufacturerlsubmitter.
6.7.3.3 Place the foot on a horizontal surface with a block of the manufacturer'slsubmitter's
recommended heel height h, placed under the heel of the foot (see Figure 2).

6.7.3.4 The effective ankle-joint centre CA lies

a) in a vertical plane passing through the longitudinal axis of the foot;

b) 80 mm above the bottom surface;

c) a quarter of the length of the foot from the most posterior part of the foot.

Dimensions in millimetres

Key
1 block of recommended heel height, hr (see 6.7.3.3)
2 longitudinal axis of foot (see 6.7.2)
CA effective ankle-joint centre (see 6.7.3)
L foot length (see 7.1)

NOTE The recommended heel height for the ankle-foot device or foot unit under test is taken as h, = 20 mm unless
otherwise specified by the manufadurerlsubmitter. (See also Figures 4 and 5.)

Figure 2 -Determination of longitudinal axis of foot (see 6.7.2) and effective anklejoint centre CA
(see 6.7.3)

-
8 I S 0 2006 All rights resenred 7
7 Test loading conditions and test loading levels

7.1 Test loading conditions

The complexity of the load actions to which the ankle-foot device or foot unit of a lower-limb prosthesis is
actually subjected during use by the amputee cannot be simulated by a single test procedure. Therefore,
several types of cyclic and static tests are specified, each applying a single or hnro different test loading
condition@).

The single test loading condition of the cyclic test is characterized by a specific profile of pulsating test force,
F,..(t) or F,(d, applied to the top of the test sample while this is supported by a foot platform which performs
angular movement following a specific profile of tilting angle, At).

The two different test loading conditions of the static tests are characterized by a specific test force, F,applied
to the top of the test sample while this is supported either on the heel or on the forefoot by a foot platform
which is fixed at a specific tilting angle, y.

Each test loading condition produces compound loadings typical of the stance phase of walking or other single
events of loading occurring in the daily use of a lower limb prosthesis by the amputee.

Each test loading condition is applicable to test samples of ankle-foot devices and foot units of any size, due
to the establishment of a relationship between the position of the top load application point PT and the foot
length L (see Figures 2, 4 and A.2).

The test loading condition(s) of each type of test are addressed in Table 12 together with their manner of
application and specified in the relevant Tables 3 to 11 of Clause 8. Further information is given in Clauses 15
and 16.

NOTE For further information see Annex A.

7.2 Test loading levels

7.2.1 The load actions referred to in the first paragraph of 7.1 vary with individual physical parameters,
locMotion characteristics of the amputee and other factors. For these reasons diierent categories of
prosthesis are needed and, consequently, different test loading levels are required, each being specified by
individual values of dimensions and loads.

The series P test loading levels designated as given in 7.2.3 shall apply to lower limb prostheses for adults.

NOTE For further information see Annex A.

7.2.2 The specification of the test loading conditions of each of the test loading levels listed in 7.2.3 is
governed by a safety concept, characterized in the following manner (see also Tables 3 and 9).

- The values of the test forces F

1, and F2unax of the cyclic test according to 16.4.1 are set at a level
which covers the full range of load actions d~sclosedby the locomotion data acquired from the group of
amputees representative of the relevant test loading level (see Annex A).

- The corresponding values of the test forces F , . , and FZspof the static proof test according to 16.2.1 and
the test forces F1, and F2, of the static ulttmate strength test according to 16.3.1 are calculated by
application of factors as speclfied in Table 3.

- The specification of all test forces takes account of records on component failures of lower limb
prostheses, taken in clinical or technical service.

7.2.3 Designation of test loading levels for adults is given below.

Test loading levels: P3, P4, P5, P6

8 8 ISO 2006 - AU rights reserved

NOTE 1 Field experience has shown that there is a need for lower limb prostheseswhich sustain loads above the level
covered by test loading level P5. In order to allow the structural testing of such prostheses on a uniform basis, test loading
level P6 has been developed for the principal structural tests and the separate structural tests on ankle-foot devices and
foot units (see Annex C).

NOTE 2 The values of the dimensions and loads of test loading levels P3, P4 and P5 are specified in separate tables
in Clause 8. As an interim measure, pending validation, it is suggested that the values of the dimensions and loads
specified in C.3 and Table C.2 are appropriate for test loading level P6. Further test loading levels will be defined, if
necessary.

8 Values of test forces, dimensions and cycles

Forces and twisting moments; segmental lengths, offsets and angles; prescribed number of cycles are
addressed.

Tables 3 to 11 describe andlor specify the values of

- test forces;
- dimensions such as segmental lengths, foot lengths and coordinates (offsets);
- cycles (prescribed number of loading cycles)

Figure 3 illustrates thresholds for the loading profile of the cyclic test.

IMPORTANT -
Annex E indicates how the adjustment of the tilting axis, TA, of the foot platform in
dependence on the foot length, L, specified by the values listed in Table 7, can be avoided or limited
by transposing the top load application point PT(see E.3.4).

Table 3 -Test forces and relevant references

Reference
Test force a Relevant
Subclause Table
test
Settling test force............................................................ F*= 0,8 F1- P m f test of
Stabilizing test force ....................................................... F- 13.2.2 5, C.1 end
attachment
Proof test force on end attachments............................... FP = 1,2 F,. upp, level
Static proof test force on heel......................................... Flw = 1,75 Fl- Static pmof
16.2.1 9, C.2
Static proof test force on forefoot ................................... Fm = 1,75 F- test

Static ultimate test force on heel

- lower level ................................................................... F i ~ , =~ , Fiw
- upper level................................................................... FlSU. upper levd = 210 Flsp
16.3.1 9, C.2
Static
ultimate
Static ultimate test force on forefoot strength test
- lower level ................................................................... F,,,,, = 195F2sp
- upper level................................................................... F a, , u ,
= 280 F,,
Pulsating test force ......................................................... Fc(t);FC(7)
1st and 2nd maximum value of pulsating test force........ Fl-. F~ 13.4.2, 9, C.2, Cydic test
lntefmediate minimum value of pulsating test force ....... 16.4.1 (10, 11) pmcedure
Fhn
Final static test force on heel Iforefoot........................... F1fin* Fa"
a h test forces F,, Fp, F,,, and F, are determined using appropriate factors.

Q IS0 2006 -All rights resecved 9

 -
Table 4 Values of bottom offsetsfBl, (heel) andfB2, (forefoot) for given values of foot length L,
relevant to the design andlor 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)

Parameter Dimension Value

Foot length L an 20 21 22 23 24 25 26 27 28 29 30 31 32

f ~ l L, = f B l . 2 d r n 6 )
f B 1 . ~ ~ mm
-32 -33 -35 -36 -38 -39 -41 -43 -44 -46 -47 -49 -50
f ~ 2 L, = f ~ 226'(L/26)
,
fB2, L a mm
105 110 115 120 126 131 136 141 146 152 157 162 167
" The Values of& ,
are determined by the condition (f ,
-fT I U, =, (fAas -A) , I(uT,28 - uA.),
For the values df4
f, see A.2.2.1 d); for the values o$.u4, dnd u
,, see Tables 6 and 7.

Table 5 -Test forces of the proof test of end attachments for test loading levels P5, P4 and P3
(see 13.2.1)

End attachments for Stabilizing Settling test Proof test

test force, force, force,
Test Test loading condition F-; (FRw) F&; (Fw) Fp; (FRpa) b
Test
loading Heel loading Forefoot loading
pm*un level F, at =- F, at y = 20" N N N
1 01 8; (1 024) 5 345; (5 376)
P5
• 1 005; (1024) 5 275; (5 376)
939; (944) 4 927; (4 956)
All tests a P4 50
926; (944) 4 863; (4 956)
rn 732; (736) 3 842; (3 864)
P3
722; (736) 3 791; (3 864)
NOTE For the a d d i i l test loading level PB the test forces are speciRed in Table C.1.
a End attachments that satisfy the shWmess requirements of the proof test of end attachments for proof test forces
of a specilk test loading h l specified in lhis table are suitable for all static and cydic tests of thls
r c ~ . # & h a r d canied out at this lparr test loading Lw* and at all lower levels.
For sets of end attachments. individually designed to the spedRc requirements of the test loading conditions of the static and cydic
tests of this International Standard andlor to the specific requirements of the ankle-foot devices or foot units submitted for test.
partiarlar conditions apply (see the OPTION dasaibed in 13.2.2.1).
The relationship between the values of F, and F, (placed in parentheses) is determined by equation (A.5), using the values of at
a d spedffed in A.2.3. The values of F, are calculated from the relevant values listed in Table A.1 (see A.2.3). using the fadm
speded in Table 3. W h i i set of values applies depends on how the assembly of end attachments is placed in the test equipment
(see13.2.2.2.3).

CO IS0 2006 -All rights

 w&r1W - 9002 OSI (a
'wUJ wz
P enlm w u W ueeq s w 'we)wu u! pesn @wexe w J O .~:sa) nJV
~ u )oolm =ww m - e ( w e 10u&sw wnplrypul
w lo w v u! wuuepep eq 0: 'we( alwe aeuy w ueamlaq I-w SBypedO % 10 mlm eyl ,
t
.L w e 1 u! m a d s w e 9 B(U -L
Y umolts s!' Irr u 0 1 - y ~
u! pa~pedspue 0. pue z s a n & j u! ufiow s!7 ul&lw:oo~
w ~ e w ! p u !se '7 Wel wo) m uo )ua~uedaps! + la m~ma c ~
'ta n Q j Y pa:wsnil! s!dn-les s!u'law w w m e veal do:
ew o: tew alwe wo4 6u!puayta s l u a w w w pue &Isn dn-:es eldwes tse: e lo
w letuewsas w seypeds 3 uurnlm -
pue 'I-el uow!ldde peal do1 ot ((3-1 ww osz =
w
w we(LWwauuor, e w 6u!pueyta sluaw43eUe pue Wsn dn-~esaldwm :w e la Wal IWWW s-s w auwnw -
'1%- uo!w!lcMe peal do:
0: aauq m luay &I!puepta s)uempe))e pua &Hsn dn-:es aldwes :sat a )o s@uq leluaur6as ey: seypads y u w n m -
m a w '3 w e a 'v sum1o3u! pa:sd a e 'gueunpew puaJO sad4 :U~W!P lo IW!W' s W e l w e w m 40 ~UORBURW
w
P 8 8 1 d m -sluewpeUe lo w&lelIW- lo suo~w(quro3WP Aq m e ! w e eq m:i o w&al I W ~ =u
€ 3-1
'I@ k w e u)&lel lewt arll
3 xwuv u! ~aypedsgd wel h!peol lse) leuon!wa erg 0: 4dde osle w6uw l e ) u a ~ eyl 310~
(mU! 7) ::(9~7)-8LS
= "n 1 '1"
QLC3 = %'k ~ L =S9z 'ln QLE = a L R ~ U l~qI o l
- - - OJaz
08 = WWWJAUV
'Vn 08 = WSw AW 'Vn
08= W&roIWJ AUV 'Vn
- - - Vn
OLC = (Vn - 3n)
- - OZP = @w W(vn - Mn) ,OSZ=~~
[08 - (9Z/7)-8f~ = vn - 'ln]
86P=Vn -%'1n
(OSZ- 1416uall e ) o l = 3n - 1 'In)
- - Mn
8zc = an - X ' l n
(00s - q16ual ( e ) o l = Mn- l 'ln)
8~ = nn - 92 'ln
- - - ',1'4
3 a tl
la~el-n
sluaurym?ue p u e 40 W u q 1quew6esp w o ~ e u ! q u r o o1eqdA1
.
saJtaur!ll!w u! suo!suaw!a
s)uewq3we pue l o sqa6uel1quew6espue seldwes as- JO w6ue11 ~ 0 19 elqel
-
(3)900z:s~9zzOSI
Table 7 -Coordinates of top load application point PTand tilting axis TA of foot platform based on
given values of foot length L, for all test loading levels

Foot length L
an
f
'0
20 21 22 23 24 25 26 27 28 29 30 31 32
Subject
8
g
n Related values off and ueffsets of PTCand TA
u
0
Direction Numerical value
and
location mm

f ~ ,=fT, 26'(W26)
Position of J;. L
17 18 19 19 20 21 22 23 24 25 25 26 27
top load All tests
application uT, L 'UT, 26'(u26)
point, PTC u ~L ,
445 467 489 511 534 556 578 ;
600 622 645 667 689 711
f&,, L = 0,365.L
Position of 'T~'L
73 1 7 7 1 8 0 1 8 4 1 8 8 1 9 1 1 9 5 1 9 9 ~ 1 0 2 ~ 1 0 6 ~ 1 1 0 ~ 1 1 3 ~ 1 1 7
tiMW axis ~ 1 tests
1
TA of food' UTA, L = 0.1.L
platform .
U ~ ~ , ~
20 21 22 23 24 25 26 27 28 29 30 31 32
NOTE The spedfied dimensions also apply to tha additional test loading level P6,specified in Annex C [see C.3 a)].
The foot length L is specified in an,taking into account that in many countries the foot size determining the foot length k measwed
in an.
The seledion of appropriate sizes of ankle-foot devices and foot units for test pwposea is not limited by the range given in this
table. The fmnulae allow the calarlatlon off- and uoffsets of P, and TA relating to any foot length L.
See 6.3 and Figures 1.4 and 5. (For fwVler information see 16.1.1 and A.2.2.3.)
See 13.4.2.3 and Figure 5. (For futher information see 16.1.1, E.3.2 and E.3.3.)

Table 8 -Angles of toe-out position of foot and specific tilting positions of foot platform,
for all test loading levels

Angles
Subject Test procedure
Event a Numerical
va~ue~degree
Toeout position of foot
(see Figure 4)
All tests - r 7

Fixed tilting positions of Static proof test and Heel loading, Fl YI - 15

foot platform static ultimate
(see 13.4.1.3) strength test Forefoot loading, F, r2 20

Instantaneoustilting
Ist maximum value, Fl- YI - 15
positions of foot platform Cydic test Intermediateminimum value, Fmn *min 0
(see 13.4.2.8)
2nd maximum value, F- Y2 20
NOTE The sp& dimensions ako apply to the additional test loading level P6,s p e M in Annex C [seaC.3 a)].
a The posithre direction of the angles rand y is shown in Figures 4 or 5, respectively.
 IS0 22675:2006(E)

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)

Test loading level (P,) and test loading

condition (F,,; F2J
P5 P4 P3

d
Unit
g -eri 6
e -4a d
- 2
e
-6,
Test procedure and test force 2 Bc.x 2 " Bfi
-
x ( 6 O(6
s4 b4 2 c 2s k
a e 2 e 2
g x s x g
LL LL LL

2227 - 2053 - 1601 -

Static proof test force N
=f F2*
- 2198 - 2 026 - 1 580
I 0
0
) -
3 340 - 3 079 - 2401 -
t
*
F ~ s u .tower l e d

F2w. -t kwd
N
3297 - 3039 - 2 369
m
Static ultimate test force
8 F1w, upper levd 4454 - 4106 - 3201 -
Frn.",,, N - 4 396 - 4052 - 3 159

'
3e
1st maximum value of pulsating
test force

.
Intermediate minimum value of
pulsating test force
F1mm

Fcmin
N

N
1273

850
- 1173

784
- 915

611
-

2nd maximum value of pulsating

N - 1 256 - 1158 - 903

-8
test force F2cmax

-*
v
Final static test force
F ~ f i n(= hy) 2227
-
- 2 053
-
- 1601
-
-
0" Fan (' F*) 2198 2026 1580
Prescribed number of cycles 1 2x lo6
NOTE The specific values of the different test forces are based on refarence values desaibed in A.2.3 and specified in TaMe A.1.
a For the additioneltest loading level P6 the vahres of the test forces and the pmcribed number of cydes are specified in Table C.2.
Key
X time in milliseconds
Y force in newtons
1 test force F

NOTE 1 The loading period of 600 ms corresponds to the average stance phase time of a typical walking cyde of 1 s
duration. (The m i n i n g time of 400 rns of the walking cyde corresponds to the swing phase.)

NOTE 2 The reference points a to h are specified in Table 10.

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

Q IS0 2006 -All rights reserved

 1s
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Compliance of an ankle-foot device or foot unit submitted for test with the performance requirements of a
specific test of this lntemational Standard shall be certified by the test laboratoryffacility only for the specific
prosthetic assembly and alignment simulated in the set-up of the batch of test samples of the ankle-foot
device or foot unit which have been subjected to this test (see 9.3).
NOTE The manufacturerlsubmitter may claim compliance also for other prosthetic assemblies andlor alignments in
which the ankle-foot device or foot unit submitted for test can be used, provided it can be certified that these lie within the
range of loading covered by the most adverse assembly and the worst-case alignment simulated in the test sample set-up
of the ankle-foot device or foot unit submitted for test.

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

9.2.1 Arrangements for testing

Batches of the part required to connect an ankle-foot device or foot unit to the remainder of a prosthetic
structure, such as an ankle-unit, ankle attachment, alignment device or pylon base, shall be tested in either of
the ways described in a) and b), depending on its combination with ankle-foot devices or foot units intended to
be allowed by the manufacturerlsubmitter.
a) If the type of connecting part is intended to be allowed for use in combination with one or several
smcified type(s) of ankle-foot device or foot unit, then batches of samples of assemblies of this part and
each specified type of ankle-foot device or foot unit shall be subjected to the tests specified in this
standard.

b) If the type of connecting part is intended to be allowed for use in combination with anv
type of ankle-foot
device or foot unit, then batches of samples of this part shall be subjected to the principal structural tests
specified in IS0 10328 in a test sample set-up in which the foot unit is replaced by a rigid lever arm, in
order to apply the longest effective lever arm possible.

9.2.2 Requirements for claiming compliance

a) In the case of 9.2.1 a), the manufacturerlsubmitter can claim compliance with this lntemational Standard
for each specified assembly of connecting part and ankle-foot device or foot unit passing the tests of this
standard, as certified by the test laboratoryffacility (see 2nd paragraph of 9.1).

b) In the case of 9.2.1 b), the manufacturerlsubmitter can claim compliance with IS0 10328 for the
'universal" connecting part passing the principal structural tests of that standard, as certified by the test
Iaboratoryffacility(see 2nd paragraph of 9.1).
NOTE Based on this daim of compliance, the manufacturer/submitter can allow the use of the 'universal"
connecting part in combination with any ankle-foot device or foot unit In order to daim compliance for such
assemblies, it is, however, necessary that the ankle-foot devices or foot units involved pass the tests of this
International Standard. (See NOTE of 9.1 .)

9.3 Number of tests and test samples required to claim compliance with this International
Standard
The minimum number of tests required for each type of test in the prescribed loading conditions in order to
claim compliance with this InternationalStandard is shown in Table 12.
The tests shall be conducted on test samples from the batch specified in Table 12 for each type of test.

The minimum number indicates, how many test samples of an anklefoot device or foot unit submitted for test
shall complete the tests without failing.

If appropriate, the tests shall be conducted in the worst-case alignment position of the test samples (see 10.6).
NOTE The total number of test samples actually needed for the conduct of all tests required may differ from the total
cfhlated by addition of the number of test samples y>ecified in Table 12 for each type of test, since the number of
substitubs needed may vary, and since test samples that have completed a specific test without failing may be used for
another test (see9.4, 16.2.1 and 16.3.1).

8 IS0 2006 -All rights reserved 17

9.4 Multiple use of test samples

9.4.1 General

Test samples, which have demonstrated compliance with the requirements of any of the tests specified in this
lnternational Standard, may be subjected to other tests of this lnternational Standard, except as stated in 9.4.2.

Any decision on the multiple use of test samples shall be based on a corresponding indication in the test
submission document (see Clause 12) andlor the agreement between the manufacturerlsubmitter and the test
laboratorytfacility.

As a general rule, any failure occurring during a test on a test sample that has previously been subjected to
another test justifies the repetition of the failed test on a substitute test sample (see Table 12).

NOTE The multiple use of test samples is speafically addressed in the static proof test (16.2.1) and the static
ultimate strength test (16.3.1 ).

Unless otherwise indicated in the test submission document andlor agreed between the
manufacturerlsubmitter and the test IaboratorytfacilQ, this lnternational Standard does not stipulate that the
tests required to claim compliance for the ankle-foot device or foot unit submitted for test be conducted in a
particular order, with the exception of the restriction specified in 9.4.2.

9.4.2 Restriction

Compliance of any test sample with the performance requirements of the cyclic test of this International
Standard can not be claimed if the test sample has previously been subjected to the static ultimate strength
test of this lnternational Standard.

9.5 Testing at particular test loading levels not specified in this lnternational Standard
For different reasons the intended use of a particular design of ankle-foot device or foot unit may require the
tests of this standard to be applied at a particular test loading level not specified in this lnternational Standard,
derived from the next lower regular test loading level of this lnternational Standard by increasing its test loads
by x %.

In this case compliance with this lnternational Standard cannot be claimed for that particular test loading level.

However, compliance with this lnternational Standard can be claimed for the next lower regular test loading
level of this lnternational Standard, from which that particular test loading level has been derived.

Reference to this lnternational Standard may also be given by stating that the prescribed batch (or batches) of
test samples of ankle-foot device or foot unit submitted for test hasl(have) been tested

a) following this lnternational Standard

or, in a more specific manner,

b) by applying the tests of this lnternational Standard at test loads set x % above test loading level P,.
 peJussar W@ IH- 9002 OSI Q
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An appropriate measure for the worstase loading is the direction and magnlude of the ankle (A-P) bending moment,
generated by the test forces applied to the heel and forefoot of the ankle-foot device or foot unit and determined by the
lengths of the effective lever arms on which these test forces ad.
Although there is a fundamental relationship between the lengths of the effective lever arms and the size of the foot, the
worst-case loading need not necessarily be provided in each case by the largest size of foot available for the test loading
level to be applied, but can also be influencedby other design parameters.

10.2 Types of test sample

10.2.1 Complete structure

Test samples representing a complete structure consist of the ankle-foot device or foot unit and the part
required to connect it to the remainder of the prosthetic structure.

If the type of connecting part used in a complete structure submitted for test according to this International
Standard has already been subjected, as a universal connecting part, to the principal structural tests of
IS0 10328 and complies with the requirements of that standard [see 9.2.1 b) and 9.2.2 b), this does not affect
the conduct or the results of the tests of this International Standard, unless the connecting part fails.

10.2.2 Partial structure

Test samples representing a partial structure consist of an ankle-foot device or foot unit as a single
component, intended by the manufacturerlsubmitter to. be connected to the remainder of the prosthetic
structure by any appropriate type of universal connecting part.

The manufacturerlsubmitter shall specify in the test submission document or agree with the test
laboratorylfacility, which type of connecting part shall be used in the set-up of test samples of this type and
shaU supply the necessary number of parts.
Types of universal connecting parts used shall comply with the requirements of IS0 10328.

10.3 Preparation of test samples

103.1 The samples shall include all parts normally fitted. This also applies to foot covers.

10.3.2 Where any test sample includes any end fittings, then it shall be assembled in accordance with
Clause 11 and the test submission document.

10.3.3 All test sample types according to 10.2 shall be given a fixed total length, using end attachments, as
required [see 13.2 and NOTE].

The fixed total length shall be determined by the dimension u - specified

~ in Table 7 and shall be achieved by
56lecting one of the combinations specified in Table 6 for different types of test sample (see 10.2) or any other
relevant combination. The combination of segment lengths selected shall be recorded.

NOTE Figure 4 illustrates a specific test sample set-up corresponding to the combination specrfied in cdumn C of
Table 7 and also marks the reasonable area for the arrangement of alternative end attachments in consideration of the
a r m t specbum of foot designs.

10.3.4 The ankle-foot device or foot unit, selected in accordance with 10.1.2, shall be submitted assembled
by the manufacturerlsubmitter at least to the part connected to the remainder of the prosthesis such as an
ankle unit, alignment device, pylon base, compliant structure or exoskeletal member. The type and
identification of the part connected shall be recorded.

The manufacturer/submitter may also attach end attachments, as required (see 11.4).

Q IS0 2006 -All rights reserved

 W&?IW - 9001 OSI Q
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1 specific arrangement of end attachment consisting of extension piece "lb" and top load application lever "la",
providing specific positionof top load application point PTOn test sample [see 10.5 d)]
2 reasonable area for the arrangement of alternative end attachments in consideration of the current spectrum of foot
designs (see NOTE of 10.3.3)
3 block of recommended heel height h, (see 6.7.3.3 and also Figure 2)
4 longitudinal axis of foot (see 6.7.2)
P, top load application point, allowing rotation of the test sample about each of the 3 spatial axes (see 13.4.1.I, 13.4.2.1
and also Figure 5)
C, effective kneejoint centre [see NOTE of 6.2 b)]
C, effective anklejoint centre (see 6.7.3)
L foot length [see 10.5 d)]
L' projection of foot length L onf-u-plane

NOTE The specific set-up illustrated in Figure 4 corresponds to the combination specified in column C of Table 6.

Figure 4 -Illustration of specific set-up of left-sided test sample with top load application point PT

11 Responsibility for test preparation

I . The manufacturerlsubmitter shall be responsible for the selection and assembly of the components to
be tested.
11.2 The manufacturerlsubrnitter shall be responsible for the provision with the test sample of specified
parts to be replaced when the number of cycles of the cyclic test has reached a value at which such
replacement is indicated [see 16.4.1.2 a)116.4.1.9].

11.3 The manufacturerlsubmitter shall be responsible for preparing the test submission document in
accordance with Clause 12.

11.4 The manufacturerlsubmitter or the test laboatorytfacility shall be responsible for the attachment of
the end attachments required (see 13.2). Whoever assembles them shall be responsible for their static
alianment in accordance with 10.5.

11.5 The manufacturerlsubmiir or the test laboratorylfacility shall be responsible for the provision of a
specific heel block (specific heel blocks) to be mounted on the foot platform(s) of the test equipment in
accordance with 13.4.1.6 and 13.4.2.5.

Whoever provides them shall be supported by the other in the following manner:

- If the manufacturerlsubmitter provides the heel block(s), the test laboratorylfacility shall contribute the
particular dimensions (and other relevant details) related to its (their) mounting and correct positioning on
the foot platform(s) of the test equipment.
- If the test laboratory/facillty provides the heel block(s), the manufacturerlsubmitter shall contribute the
particular dimensions (and other relevant details) related to its (their) shape, specified in accordance with
13.4.1.6 and 13.4.2.5. This informationshall be included in the test submission document [see 12.3.2 f)].

If appropriate, the manufacturer/submitter shall specify in the test submission document the positiin of the
heel block relative to the position of the ankle-foot device or foot unit in the test set-ups in accordance with
13.4.1.6 c) 2) and 13.4.2.5 [see 12.3.2 e)].

11.6 The test laboatorylfacility shall be responsible for the verification that the test sample is assembled in
accordance with Clause 10, the test submission document (see Clause 12) and the manufacturer'slsubmitter's
written instructions supplied with every component of the type.

Q IS0 2006 -All rights reserved

 If the test sample assembly is not correct the test laboratorylfacility shall, in consultation with the
manufacturerlsubmitter, alter it to the specified configuration.

11.7 The test laboratoryhcility shall be responsible for adjustment of the alianment to give the correct
dimensions during test in accordance with 10.5 (see also 16.2.1. , 16.3.1.2116.3.1.8 and 16.4.1.3).

11.8 The test Iaboratorytfacility shall be responsible for the verification that the design of the heel block(s)
is in accordance with the requirements of 13.4.1.6, 13.4.2.5 and the test submission document [12.3.2 e) and
12.3.2 91.

If the design of the heel block(s) is not correct, the test laboratorylfacility shall consult with the
manufacturer/submitter to decide who alters it (them) to the specified design.

11.9 The test laboratoryhcility shall be responsible for the mounting and correct positioning of the heel
Mock(s) on the foot platform(s) of the test equipment in accordance with 13.4.1.6, 13.4.2.5 and the test
submission document [12.3.2 e) and 12.3.2f)].

12 Test submission document

12.1 General requirements

1:
12.1.1 The manufacturerlsubmitter shall prepare the test submission document with any associated
> information and shall provide at least one copy with the batch of test samples of every ankle-foot device and
foot unit submitted for test.
i
. 12.1.2 The manufacturerlsubmittershall, if appropriate, state in the test submission document which of the
information to be recorded in the test log in accordance with this International Standard shall be included in
the test report in addition to the information required to be included according to Clause 18.
1 12.1.3 The manufacturerlsubmitter shall clearly indicate a name and address for communication purposes. If
1 appropriate, the identity of the original equipment manufacturer shall be provided.

12.1.4 The manufacturerlsubmitter shall provide a unique and traceable identification for the test submission
document which shall also be indelibly marlted on the test sample. The manufacturerlsubmittershall maintain
a record of such identification.

12.1.5 The manufacturerlsubmitter shall dearly indicate the test laboratorytfacility required to condud
the test.

12.1.6 The manufacturerlsubmitter shall clearly indicate the date of submission or dispatch to the test
laboratorylfacilrty.

12.2 Information required for test samples

The following information, attributable to a fully traceable identification for each test sample, shall be included
in the test submission document:

a) manufacturer's name and model identification andlor number-orother means of identiition;

b) any certification from the manufacturer which states that the test sample has been taken from normal
production and which gives details of the method of selection, in accordance with 10.1.I;

c) type of ankle-foot device or foot unit, in accordance with 10.2.1 or 10.2.2;

d) statement with justification that the size of foot selected provides the worst-case loading, in accordance
with 10.1.2;

Q IS0 2006 -All rights rssenred

 e) if not straightforward, identification of the longitudinal axis of the foot (6.7.2) and the position of the
effective ankle-joint centre CA (6.7.3), in accordance with 10.5;

9 information related to particular arrangements concerning the part required to connect the ankle-foot
device or foot unit submitted for test to the remainder of the test sample, in accordance with 9.2.1;

g) identication of the worst-case alignment position in accordance with 10.6;

h) any special assembly instructions for the test sample andlor attachments, in accordance with 10.3;
i) type of end attachments and their static alignment, in accordance with 10.3, 10.5 (and 11.4).

I 12.3 Information required for tests

I 12.3.1 General

The information addressed in 12.3.2 to 12.3.5 for each test sample shall be included in the test submission
document.
I
12.3.2 For all tests

a) the particular test requested (Clauses 9 and 16) and the test loading condition(@and test loading levels
[Clauses 7 and 8 (and Annex C)];
b) particular values of dimensions and forces for the conducting of the test (Clause 8);
c) the worst-case alignment of the test sample (10.6);
d) information related to particular arrangements concerning the part required to connect the ankle-foot
device or foot unit submitted for test to the remainder of the test sample (9.2.1);
e) the position of the heel block relative to the position of the ankle-foot device or foot unit submitted for test
in the test set-ups (11.5);
9 the dimensions (and other relevant details) of the design of the heel block that are related to the shape of
the foot sole of the ankle-foot device or foot unit submitted for test [only if the test laboratorylfacility
provides the heel block(s) (1131.

I 123.3 For the static proof test and the static ultimate strength test

The request to proceed with the test procedure in the second direction of loading on the occurrence of failure
in the test procedure in the first direction of loading in accordance with 16.2.1.5 and 16.3.1.6.

I 12.3.4

a)
For the static ultimate strength test

if appropriate, request for continuation of the test until failure actually occurs in accordance with 16.3.1.5
and 16.3.1 .I 1 and recording of ttie value of the failure load and any further instructions concerning the
documentation of test results;

I b) the application of an increased rate of loading in accordance with 16.3.1 .l,

Annex B.

12.3.5 For the cyclic test

16.3.1.5, 16.3.1.1 1 and

a) the test frequency called for in accordance with 16.4.1.7 and 16.4.1.8;
b) replacement intervals of service items in accordance with 16.4.1.2 a) and 16.4.1.9;
c) if appropriate, request for visual examination with specification of magnification in accordance with
16.4.1.2 c) and 16.4.1.14. This request shall include instructions concerning the documentation of test
results.

Q IS0 2006 -All rights resenred 25

13 Equipment
13.1 General
The different types of test listed in Table 12 and specified in Clause 16 require different types of test
equipment specified in 13.4.
Each piece of test equipment shall provide sufficient freedom of movement for the test sample to permit and
not restrict its deformation under load within the specified range.
Other pieces of equipment are end attachments (see 13.2) required for specific set-ups of test samples, a
special jig that may be used on an optional basis to facilitate the setting-up of test samples (see 13.3) and any
devices used to measure loads and dimensions (not specifically addressed).

13.2 End attachments

13.2.1 General
For the application of the test loading conditions specified in this lnternational Standard, the test sample set-
up requires the use of end attachments, consisting of non-prosthetic extension pieces and any appropriate top
load application adaptor or lever, as required.
The end attachments shall not enhance or reduce the specified test loads in the structure under test.
The end attachments shall satisfy the requirements of the proof test of end attachments specified in 13.2.2.

13.2.2 Proof test of end attachments

13.2.2.1 General
The test shall be carried out on end attachments required for the application of the test loading condiions
specified in this lnternational Standard. End attachments which satisfy the stiiess requirements of this test
,
for proof test forces Fw = 1,2 F,,, up kw, of a specific test loading level (see Tables 3, 9 and C.2) are
suitable for all static and cyclic tests &is lnternational Standard carried out at this specific test loading level
and at all lower levels.
OPTION -If it is intended to use different sets of end attachments, individually designed to the specific
requirements of the test loading conditions of the static and cyclic tests of this lnternational Standard (see
EXAMPLE) and/or to the specific requirements of the ankle-foot devices or foot units submitted for test, the
proof test of end attachments shall be applied to each of these sets. In this case each set shall satisfy the
stiffness requirements of the proof test of end attachments at values of test force F a relating as shown in
Table 13 to the highest value of test force F, Fsp or F,, (see Tables 3. 9 and C.2) $ be applied during the
test for which this set has been designed.

EXAMPLE A particular reason for the use of a specific set of (light-weight) end attachments for the cyclic test is the
reduction of inertia effects caused by the mass of (heavy-weight) universal end attachments suitable for all tests.

It is not necessary to repeat the proof test of end attachments if earlier results for previously tested relevant
combinations of end attachments are available and are suitable.

Table 13 - Option for end attachments of specific design

Intended use of end attachments Test force to be applied
For the static ultimate strength test Fm= 1'2 FwU-w
For the static proof test Fm = 1,2 F,
For the cydi test F~ = 1,2 F~ = 2,l F-a
''
The velue of test force to be applied to end attachments intended to be used for cydic tests takes into accoimt that each tecd
sample b v h g passed the cyclic test is subjected to a final static test without preceding re-alignment. The fatter condition can
hardly be met if the procedure requires the exchange of end attachments, which would be the case if the set-up of the test sample
for the Wlc test contained end attachments spedfically designed for cydic tests only.

Q IS0 2006 -All rights rescwved

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13.2.2.2.5 Apply to the bottom and top load application points of the assembly the stabilizing test
force Fstabor F W b (see 13.2.2.2.3), specified in Table 5 or Table C.l, and maintain it until the measurement
specified below IS completed.

Measure and record the displacement, 6of the moving load application point from its reference position in the
test equipment as 6,.

13.2.2.2.6 Increase the test force F smoothly at a rate of between 100 Nls and 250 Nls to the proof test
force F or FRpa(see 13.2.2.2.3) of the relevant (test loading condition and) test loading level, specified in
Table F o r Table C.l (but see the OPTION described in 13.2.2.1), and maintain it until the measurement
specified below is completed.

Measure and record the displacement, 6of the moving load application point from its reference position in the
test equipment as 4.

Record the application of a specific value of proof test force Fpaor FRpa,determined in accordance with the
OPTION described in 13.2.2.1.

13.2.2.2.7 Decrease the test F force to F,tabor FRstab

and maintain it until the measurement specified below
is completed.

Measure and record the displacement, 6 of the moving load application point from its reference position in the
test equipment as 4.

13.2.2.2.8 Calculate and record the deflection, D l , at FPaor FRpaand the permanent deformation, D2,
at Fab or FRstab
as follows:

13.2.2.2.9 Do not use the end attachment if the calculated values exceed the following limits:

maximum deflection at Fpaor FRpa: D, = 2 mm.

maximum permanent deformation at Fstabor FRshb: D2= 1 mm.

13.2.2.2.10 Record the results.

13.3 Jig (optional)

ig may be used to facilitate the setting-up of test samples before mounting them in the test equipment.
Aj

13.4 Test equipment

13.4.1 Test equipment to perform statlc heel and forefoot loading

13.4.1.1 The test equipment shall be capable of producing static test forces at a loading rate of between
100 N/s and 250 Nls (but see NOTE) up to the values specified in Table 9 or Table C.2 for the relevant test
procedure, test loading condition and test loading level.

NOTE For the alternative static ultimate strength test according to Annex B, inmased loading rates of bebeen
1 kN/s and 5 kNls are considered to be appropriate.

The test equipment shall allow the adjustment of the position of the top load application point PT to thef and
mflsets relevant to the foot length L of the ankle-foot device or foot unit of the test sample, specified in
Table 7 and illustrated in Figures 4 and 5. (For further background information see A.2.2.3.)
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EXAMPLE For a foot of length L = 27 an and a recommended heel height of h, = 10 mm, a heel block with a
cylindrical front section defined by a radius of R = 120 mm has been shown to be appropriate.
NOTE For the provision of specific heel blocks see Clause 11.

13.4.2 Test equipment to perform cyclic loading

NOTE The test equipment to perform cydic loading may also be used to perform static loading. In this case it is
recommended that means be provided to lock the foot platform in the relevant position to facilitate its adjustment and to
avoid overloading of the tilting drive mechanism (see Figure 5).
13.4.2.1 The test equipment shall be capable of producing pulsating (compression) test forces F, up to the
magnitudes and rates of loadinglunloading specified in Tables 9, 10 and II for the relevant test loading
condiiion and test loading level.

The test equipment shall allow the adjustment of the position of the top load application point PT to they and
U-offsets relevant to the foot length L of the ankle-foot device or foot unit of the test sample, specified in
Table 7 and illustrated in Figures 4 and 5. (For further background information see A.2.2.3.)
The connection between the test equipment and the test sample at the top load application point PT shall
allow rotation of the test sample about each of the 3 spatial axes (see also Figure 5).

13.4.2.2 The test equipment shall incorporate a tiltable foot platform capable of supporting the ankle-foot
device or foot unit of the test sample when the pulsating test force referred to in 13.4.2.1 is applied
(see Figure 5).

13.4.2.3 The test equipment shall allow the adjustment of the position of the tilting axis TA of the foot
platform (see Figure 5) to the values of fTA and UTA relevant to the foot length L of the ankle-foot device or foot
unit of the test sample, specified in Table 7. (For further background information see E.3.2 and E.3.3.)

13.4.2.4 The foot platform shall support the ankle-foot device or foot unit at values of tilting angle y
oscillating through the range from heel contact to toe-off specified in Table 11 and illustrated in Figure 6.
NOTE Test equipment other than that addressed, described or referred to in this International Standard
(see paragraphs 3 and 4 of 15.1) may use a foot platform fixed horizontally and apply the specified values of tilting angle
to the test sample.
13.4.2.5 The foot platform shall be equipped with a heel block that satisfies the same requirements as the
heel block of test equipment to perform static heel and forefoot loading (see 13.4.1.6).

13.4.2.6

a)
In addition, the test equipment shall satisfy the following requirements:

The test equipment shall be capable of lifting the test sample off the foot platform for the period of
I
unloading corresponding to the swing phase of walking, during which the foot platform returns to its
starting position for the next loading cycle (see Figure 5).
NOTE The example illustrated in Figure 5 produces a lifting force Fm, the magnitude of which depends on the
W i n of the test equipment and the mass of the test sample set-up.

b) The test equipment shall incorporate a means to ensure that the foot of the test sample contacts the foot
platform in the correct position for the next loading cycle.
NOTE This is important, since foot contact on the platform in an incorrect position will change the test loading
conditions. For example, foot contact on the platform in an incorrect position in the f-u-plane will change the
relationship between the test force F applied to the test sample in the top load appliitiin point PT and the forces
acting between foot and platform, comprising the perpendicular and tangential force components Fp and FT and their
resultant FR [* A.2.2.1 a)]. Consequently, foot contact in i n c o w position may impair the conformity of tests and
the comparablllty of test results.
Appropriate means to ensure foot contact on the platform in the correct position are flexible elements,
which act during the lift-off phase of the test sample to compensate dislocation of the foot that may have
occurred during the previous loading cycle and to stabilize the foot in the correct position by resisting
dislocation in the manner specified below [see also NOTE and EXAMPLE in 3) as well as Figure 51.
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13.4.2.8 The profile of the tilting angle fit) is primarily specified by the instantaneous tilting positions y,,
smin and (see Table 8) occurring at , , lF (1st maximum), Fmin (intermediate minimum) and F2an,
(2nd maximum) of the loading profile (see 13.4.2.9).

The profile of the tilting angle fit) can also be specified with sufficient accuracy by a polynomial of 5th degree.
For the period of 0 ms G t G 600 ms corresponding to a loading period of 600 ms (see NOTE I), the
polynomial reads:

NOTE I The loading period of 600 ms corresponds to the average stance phase time of a typical walking cycle of 1 s
duration. (The remaining time of 400 ms of the walking cyde corresponds to the swing phase.) Simulating this stance
phase time-swing phase time-relationship in a cyclic test, a loading period of 600 ms corresponds to a test frequency
f = 1 Hz.

NOTE 2 For other test frequencies, preferably between 0,5Hz and 3 Hz (see 16.4.1.7 and 16.4.1.8), Equation (3)can
be adapted by multiplyingeach coefficient of the polynomial by (600ms/x msy, the value of x corresponding to the loading
period related to a different frequency, and the value of y corresponding to the exponent of the time t related to each
coefficient, i.e. for the adaptation of the polynomial to a loading period of x = 900 ms the coefficients had to be multiplied
by (6001900)"= (213)"as follows: 2,450 74 x1V12x (2/3)=;3,759 84x lo4 x (213)" etc.

Further guidance on the application of the profile of the tilting angle fit) is given in Table 11.

13.4.2.9 The pulsating test force Fc(t) according to 13.4.2.7 a) and Figure 6 is primarily specified by the
following data (see Table 9):

- The test force, ,1

F at the 1st maximum of the loading profile, occurring at 25 % of the loading period
(see NOTE I),

- the test force Fminat the intermediate minimum of the loading profile, occurring at 50 % of the loading
period (see NOTE I )

and
- the test force F2an, at the 2nd maximum of the loading profile, occurring at 75 % of the loading period
(see NOTE I).
NOTE 1 For a loading period of 600 ms, as shown in Figures 3 and 6 and Tables 10 and 11, the percentiles 25 %,
50 % and 75 % of the loadii period correspond to instants of 150 ms, 300 ms and 450 ms after the beginning of the
loading period (see also NOTE 1 of 13.4.2.8).

The profile of the pulsating test force F,(t) can also be specified with sufficient accuracy by a polynomial of
6th degree. For the period of 0 ms s t s 600 ms corresponding to a loading period of 600 ms (see NOTE Iof
13.4.2.8), the polynomial reads:

NOTE 2 For the adaptation of Equation (4) to other loading periods related to diirent test frequencies, the method
desaibed in NOTE 2 of 13.4.2.8 applies.

Further guidance on the application of the profile of the test force Fc(t) is given in Tables 10 and 11 and
Figure 3.

13.4.2.10 The waveforms of the pulsating test force Fc(t) or F,()j and the tilting angle fit) of the oscillating
foot platform generated by the test equipment'shall be smooth with no overshoot spikes, characterized by a
course corresponding to the descriptions given in 13.4.2.8 and 13.4.2.9.

0 IS0 2006 -All rights regenrad

13.4.2.11 The test equipment shall switch off, if the pulsating test force F,(t) or F,(fi and/or the tilting
angle At) of the oscillating foot platform exceed the tolerances specified in 14.3 9, g) and h), with the
exception specified in 13.4.2.12.

13.4.2.12 If the test equipment control mechanism used to generate the pulsating test force F,(t) or F,(fi
requires a number of cycles to achieve the prescribed loading profile, during this settling in period the
waveform of the test force shall be smooth with no overshoot spikes, and the highest force applied to the test
sample shall not exceed the maximum test force F,,, by more than 10 %.

NOTE Experience has shown that the repeated loading at values exceeding the maximum test force F,,, by more
than 10 % can cause an early deterioration of the test sample.

dB IS0 2006 -All rights resenred

Pwm s)q@ Iltl 9002 OSI Q
-
-(gc) a6ed 6upe4 aas g a ~ n 6 !01
j Aay pue puabl ~ o j
~ ~ 9 ~ ~
( 3 ) 9 0 0 ~ :OSI
1 specific arrangement of end attachment consisting of extension piece 'Ib' and top load application lever 'la",
providing specific position of top load application point PTon test sample [see 10.5 d)]
2 reasonable area for the arrangement of alternative end attachments in consideration of the current spectrum of foot
designs [see NOTE of 10.3.31
3 example of appropriate means to flexibly resist dislocation of the foot in thef-uplane during the lift-off phase of the
test sample to ensure contact of the foot on the foot platform in correct position for the next loading cyde
[see 13.4.2.6 b)]
4 blodc of recommended heel height hr with cylindrical shape of its top surface to provide a smooth transition towards
the forefoot [see 13.4.1.6 and 13.4.2.51
5 point of intersection of line of transition between plane rear section and cylindrical front section of top surface of heel
block and u-axis [see 13.4.1.6 c) 2)],
6 tiltable foot platform:
- either fixed at the values of tilting angle y, and y2 specified for static heel and forefoot loading (see 13.4.1.3)

- periodically oscillating with fit) within the range specified for progressive heel and forefoot loading from heel contact
to toe-off (see 13.4.2.4)

7 means of locking the foot platform at the values of tilting angle y, and y, specified for static heel and forefoot loading
(option - see NOTE of 13.4.2)

F test force Fc(t) or Fc(yj, Fw or Ffi,, F,

Fm lifting force to lift the test sample off the foot platform during the period corresponding to the swing phase of walking
[see NOTE of 13.4.2.6 a)]

WI stabilizing forces at specific u-level according to 13.4.2.6 b) I ) (sameeffect as stabilizing moments MIin PT)

MI stabilizing moments in PTaccording to 13.4.2.6 b) 1) (same effect as stabilizing forces fFI)

MI stabilizing moments in PT according to 13.4.2.6 b) 2) (corresponding stabilizing forces at specific u-level not shown)

M,,, stabilizing moments in PTaccording to 13.4.2.6 b) 3) (correspondingstabilizing moments or force couples at specilic
devel not shown)

PT top load application point, allowing rotation of the test sample about each of the 3 spatial axes (see 13.4.1.1,
13.4.2.1 and also Figure 4)

C, effective kneqoint centre [see NOTE of 6.2 b)]

C, effective anklejoint centre (see 6.7.3)

TA tilting axis of foot platform (see 13.4.2.3)

L foot length [see 10.5 d) and Figure 41

L projection of foot length L onfu-plane (see Figure 4)

Figure 5 -Diagrammatic view of test equipment according to 13.4.1 and 13.4.2 with test sample

Q IS0 2006 -All rights resewed

 plepuqs leuogeurqul s!w 40 1sel3!13b lo uol~puo3Bu!peol ew Bu~u~uuelep
'eur~ pue (r)=dem04 asq 40 styyard I) ern61d
p suo~3un)pezjuartpuh se (r)l elsue 6 u n l ~ -
('aseqd 6ups a~#08 spuodsaucx, apk Bu!ylemaqt 40 sw 00p p aug Bu!u!ew arU)-uownp s c 40
apk &I!ylem 1m!d4e 40 awg aseqd m ew a6eme a* a)spuodsaucx, sur 009 40 w ad 6u!peo1a l u 310~
ZAt tlA
009 OOE 0
oz- OOP
ooz-
0
OOZ
OOP
009
008
000 1
OOZ C
OOP C
(3)900z:9~9zzOSI
Key
X angle in degrees
Y force in newtons

Figure 7 -Test force F,(y) of test loading level P5 as function of tilting angle At) of foot platform

14 Accuracy

14.1 General

Details of methods used to measure accuracy shall be recorded.

The test equipment, any jig used for the setting-up of test samples and any devices used to measure loads
and dimensions shall be calibrated at least annually and whenever any part is replaced. Records of the
calibration shall be maintained.

14.2 Accuracy of equipment

In order to meet the accuracy of procedure specified in 14.3, the test equipment, any jig used for the
setting-up of test samples and any measuring devices should be capable of measuring a) to d) to the
accuracy specified.

a) linear dimensions to an accuracy of ~t0,2 mm;

b) angular dimensions to an accuracy o f f 0,T;

c) test forces to an accuracy off 1 % of the highest value required in the test;

d) the frequency of cyclic tests to an accuracy of within 1 % of the test frequency used.

-
Q IS0 2006 All rights m e n d
14.3 Accuracy of procedure

a)
*Linear
1 mm.
dimensions, except segment lengths, shall be initially set and finally adjusted with a tolerance of

b) Segment lengths shall be set with a tolerance of * 2 mm.

c) Angular dimensions, except the angular toe-out position of feet, shall be set with a tolerance of + 1"
d) The angular toe-out position of feet shall be set with a tolerance of i 3".

e) Static test forces shall be applied with a tolerance of i 2 % of the highest value prescribed for the test.

f) The pulsating test force Fc(t) or FC(dshall be applied with a tolerance of i 3 % of the value prescribed for
,,,F
, at the instants of:

- the 1st maximum F,.,,at t, = 150 ms and y, = - 15";

- the intermediate minimum Fminat tFmi, = 300 ms and wmin = 0";
- the 2nd maximum F
,&
, at t2 = 450 ms and g = 20".

g) The tilting angle At) of the oscillating foot platform shall be applied with a tolerance of
of
*2 O at the instants

- emin= O0 at tFanin = 300 ms;

- a = 20° at ,t = 450 ms.

h) The frequency of cyclic tests shall be controlled with a tolerance of i 10 % of the test frequency used.

15 Test principles

15.1 General
The static and cyclic test procedures for prosthetic ankle-foot devices and foot units addressed in the scope
Clause 1 and specified in this International Standard use static and cyclic strength tests that simulate the
loading condiiins typical of normal use as described in a) to d).

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.

The description of the test principles given in a) to d) is closely related to a specific type of test equipment as
described in 13.4.1 and 13.4.2, which is considered to require the lowest complexity possible. (See also
16.1.1, 16.1.2 and Annex E.)

This relationship between test principle and test equipment is, however, not imperative. Moreover, any other
type of test equipment may be used, provided it is capable of applying the forces and displacements in
accordance with the requirements specified in clauses 7,8, 13, 14, 15 and 16.

a) The test sample, consisting of the ankle-foot device or foot unit and the end attachments required for the
test sample set-up, is set up in the test equipment in a position determined by its suspension in the top
load application point PT and the placement of its foot on the foot platform, allowing
deflectionJdeformationunder load.

8 IS0 2006 -All rights mewed

b) The range of angular movement from heel contact to toe-off in the progression of the limb during the
stance phase of walking, characterized by the (lower) leg angle in the sagittal plane as a function of time,
or any specific instant of this angular movement is simulated by corresponding tilting of the foot platform
of the test equipment as a cyclical oscillation within a given range of tilting angle or at fixed values of
tilting angle (see 16.1.2).

c) The loading exerted on the ankle-foot device or foot unit of the lower limb prosthesis by the amputee
during the stance phase of walking is simulated by a single test force, applied at the top load application
point PT of the test sample, while this is supported by the tiltable foot platform of the test equipment.

d) The top load application point PT is the point of intersection of the lines of action of the resultant reference
forces FR1and FR2,determining the directions of the static and the maximum cyclic heel and forefoot
reference loading.

According to the concept applied to the static and cyclic test procedures of this lnternational Standard,
the position of the top load application point PT, determined by itsf- and u-coordinates, is only dependent
on the foot length L of the ankle-foot device or foot unit submitted for test. It is not dependent on the test
loading level. This allows the application of the static and cyclic test procedures of this International
Standard at any of the test loading levels specified to test samples of ankle-foot devices or foot units of
any size of foot.

NOTE For further backgroundinformation see Annex A.

15.2 Static test procedure

The static test procedure consists of a proof test (16.2) and an ultimate strength test (16.3). This test
procedure is carried out to determine the performance of the load bearing structures under typical severe
loading conditions that can occur during use by users as occasional single events.

15.3 Cyclic test procedure

The cyclic tbst procedure (16.4) consists of repeated applications of a prescribed load to a test sample with
loading conditions typical of normal walking, followed by a final static test (16.4.1.1 1) for which the loading and
unloading procedures of the static proof test (16.2) apply.

16 Test procedures

16.1 Test loading requirements

16.1.1 Preparationfor test loading

The preparation for test loading shall proceed as described in a) to d).

NOTE 1 For test equipment other than that addressed, described or referred to in this lnternational Standard
(see paragraphs 3 and 4 of 15.I),the steps of preparation for test loading may differ from those described in a) and b).

a) For the static test ~rocedure[see 15.2 and 16.1.2 a)] prepare the test equipment as follows.

1) Set the foot platform to a position that allows it to support the entire foot of the test sample when this
is mounted in the test equipment in accordance with d).

NOTE 2 This is to ensure that

- for heel loading, the foot platform supports the forefoot, if heel loading by the test force F, defonns the test
sample to such an extent that forefoot support is necessary to avoid unrealistic condiions of loading and
- for forefoot Wi, the foot platform supports the heel, if forefoot loading by the test force F, deforms the
test sample to such an extent that heel support is necessary to avoid unrealisticcondiions of loading.
 2) Set the foot platform at one of the tilting angles, y, or y2 (see Table 8).

3) Mount the specific heel block on the foot platform and position it so that

- the line of transition from the plane rear section to the cylindrical front section of its top surface
intersects thef-u plane perpendicularly [see 13.4.1.6 c) I ) ] and

- the point of intersection lies on the u-axis of the test sample [see d)] or is offset from the u-axis
[see 13.4.1.6 c) 2)] as specified by the manufacturerlsubmitter in the test submission document
[see 12.3.2 e)].

4) If appropriate (see NOTE 3), set the top load application point, PT horizontallv, to a distance from the
tilting axis, TA, determined by the difference of theirf-offsets fiA,-fT,L) relevant to the foot length
L of the test sample (see Table 7 and Figure 5).

NOTE 3 The static test procedure is carried out with the foot platform set to a fixed tilting angle [see a) 2)],
hence, the position of the test sample set-up in the test equipment set with step d) 2) will not be changed by
oscillation of the foot platform typical of the cyclic test procedure. Therefore, the position of the tilting axis, TA of
the foot platform determined by the offsets fTA, and *A, is less important than for the cyclic test procedure.
This aspect is relevant in particular, if the static and the cydic test procedures are carried out on different test
equipment.

5) Set the top load application point, PT m, to a position that allows the offset u, relevant to the
foot length L of the test sample (see Table 7) to be established when setting /t up in the test
equipment [seed)], the offset u ~ , to be measured from the u-level of that point on the contact
surface of the foot platform tilted at yl or y2 (see Table 8), at which the posterior heel edge or the
point of the foot of the test sample will be positioned upon its correct setting-up in the test equipment
[see d), Figure 8 and NOTE 41, and which provides sufficient travel for the moving part of the
actuator.

NOTE 4 As illustrated in Figure 8, in the setting-up described in the foregoing paragraph the straight line
passing through the top load application point PTparallel to the u-axis intersects the contact surface of the foot
platform at a distance (uT+ h T ) . This distance can be calculated by factoring the value of ,u, relevant to the
foot length L as specified in Figure 8 for static heel and forefoot loading at y, or y,. The vertical setting of the top
load application point at this distance is considered to be one appropriate way of preparing the test equipment
for static loading as required.

b) For the cvclic test ~rocedure[see 15.3 and 16.1.2 b)] prepare the test equipment as follows.

1) Establish a distance between the tilting axis, TA, and the contact surface of the foot platform
corresponding to the value of UTA, relevant to the foot length L (see Table 7, Figure 5 and E.3.2.2).

2) Set the foot platform to a position which allows it to support the entire foot of the test sample when
this is mounted in the test equipment in accordance with d).

3) Temporarily fix the foot platform in its neutral tilting position ( y = 0) so as to simulate the ground.

4) Mount the specific heel block on the foot platform and position it so that

- the line of transition from the plane rear section to the cylindrical front section of its top surface
intersects thefu plane perpendicularly [see 13.4.1.6 c) I)]
and

- the point of intersection lies on the u-axis of the test sample [(see d)] or is offset from the u-axis
[see 13.4.1.6 c) 2)] as specified by the manufacturerlsubmitter in the test submission document
[see 12.3.2 e)].

5) Set the top load application point, PT horizontally, to a distance from the tilting axis, TA, determined
by the difference of their f-offsets fiA - fT relevant to the foot length L of the test sample
(see Table 7 and Figure 5).

O IS0 2006 - All rights reserved

 6) Set the top load application point, PT vertically, to a position that allows the offset uT relevant to the
foot length, L of the test sample (see Table 7) to be established when setting h up in the test
equipment [see d)], the offset ,u, to be measured from the horizontal contact surface of the foot
platform, and which provides sufficient travel for the moving part of the actuator (see Figure 5).

c) Assemble the test sample to a fixed length, using end attachments consisting of extension pieces and any
appropriate top load application adaptor or lever relevant to the test sample set-up (see 10.2 and 10.3
and Table 6), and align it to the values specified in Tables 7 and 8 as described in 10.5 and illustrated in
Figure 4.

d) Set the test sample set-up in the test equipment

1) with the ankle-foot device or foot unit placed on the foot platform in either of the ways referred to in a)
and b) and in the toe-out position specified in Table 8 and illustrated in Figure 4 and

2) with the u-axis extending parallel to the line of action of the moving part of the actuator at a horizontal
distance from the tilting axis TA of the foot platform determined by fTA, relevant to the foot length L
of the test sample (see Table 7) when the top load application point, PT of the test sample is
matching the top load application point, PTof the test equipment (see Figure 5).

NOTE 5 For some designs of ankle-foot devices and foot units it may not be possible to set up a test sample in
accordance with these requirements. Special test set-ups may then be used in certain cases.

e) Arrange the means to resist dislocation of the test sample during its lift-off phase, in accordance with
13.4.2.6 b) and Figure 5. Adjust the means so that the foot of the test sample contacts the foot platform
for the next loading cycle in the position determined by the test set-up according to d).

f) Do not alter the set-up described in a) to e) if the test sample deflects under the test loading conditions
specified in Clause 8 during the tests specified in 16.2, 16.3 and 16.4.

Q IS0 2008 -All rights resewed

[(e C ' 1 . 9 ~
aas] ernpemd a
m an-s JO 6u!peo( asaj JOJ uop.~llderd- 8 ern6!j
In L L ' L . = Z ~ P L ~ + ~ l n m ' =Llw
~ +41
L L'O = zA Uue) (Y- -7SL'O) = Zlw
- 4 PO'O = 51 u q - (Y+.7 SZ'O) = ' 4 7
ZA )e ~ ! W OIIW a o l qIWS 51 le 6u!~eo(I-q WWS
(3)900z:s~9zzOSI
16.1.2 Test loading conditions

The test loading shall be applied in different conditions, described in a) and b).

NOTE 1 For test equipment other than that addressed, described or referred to in this International Standard
(see paragraphs 3 and 4 of 15.I),the application of the test loading may differ from that described in a) and b).

a) The static tests shall apply separate heel and forefoot loading to the test sample of ankle-foot device or
foot unit in directions and at magnitudes relating to the maxima occurring early and late in the stance
phase of normal walking respectively.

With the test sample set-up according to 16.1.1, these loading conditions are determined by the values of
the test forces F, and F2specified in Table 9, to be applied at the top load application point, P , and by
the tilting angles y, and y2 of the foot platform, specified in Table 8.

NOTE 2 The conditions of heel and forefoot loading specifed for the static tests shall also apply for the instants of
maximum heel loading (1st maximum) and maximum forefoot loading (2nd maximum) during the cydic test
addressed in b).

b) The cyclic test shall apply progressive loading to the sample of ankle-foot device or foot unit in directions
and at magnitudes representative of the full stance phase of walking from heel contact to toe-off.

With the test sample set-up according to 16.1.I, this loading condition is determined by the profile of the
test force F, to be applied at the top load application point, PT, and by the profile of the tilting angle, yof
the foot platform, the profiles of test force, F
, and tilting angle, y to be applied either as synchronized
functions of time F,(t) and At), or the profile of the tilting angle y to be applied as a function of time At)
and the profile of the test force Fcto be applied as function of the tilting angle FC(d (see 13.4.2.7 and
Figures 6 and 7).

The profile of the test force F,(t) is determined by the instantaneous values of test force, ,1 F
(1st maximum), Fmin (intermediate minimum) and FZm, (2nd maximum), specified in Table 9, by
additional 'thresholds" illustrated in Figure 3 and specified in Table 10, by discrete values specified in
30 ms time increments in Table 11 and also by equation (4) of 13.4.2.9.

The profile of the tilting angle, At), is determined by the instantaneous values of tilting angle, n. y~~~~
and at the instants,of, ,F (1st maximum), Fmi,! (intermediate minimum) and FZm, (2nd maximum),
specified in Table 8, by discrete values specified in 30 ms time increments in Table 11 and also by
equation (3) of 13.4.2.8.

NOTE 3 The lines of application of the static and maximum cydic heel and forefoot reference loading are intended to
approach those determining the sagittal plane loading of the corresponding test loading conditions I and II of the principal
structural tests of IS0 10328, while the values of tilting angle of the foot plafform are adually identical with those specified
for heel and forefoot loading of the separate structural tests on ankle-foot devices and foot units of IS0 10328 (For fumer
b8ckground information see Annex A).

16.2 Static proof test

16.2.1 Test method

16.2.1.1 The static proof test for ankle-foot devices and foot units shall be conducted by applying the test
force initially to the heel and subsequently to the forefoot of the same test sample, as described in 16.2.1.2 to
16.2.1 .lo, or vice versa.

The static proof test for ankle-foot devices and foot units may be carried out as part of the alternative static
ultimate strength test specified in Annex B [see also 16.3.1, Clause B.l and B.2 c)].

A flowchart for this test is shown in Figure 9.

16.2.1.2 Prepare and align a test sample from the batch specified in Table 12, for this test, in accordance
with 9.4, Clauses 10 and 11, 12.2 and 16.1.1 c) and Tables 6, 7 and 8.

If a test sample that has completed the cyclic test procedure for ankle-foot devices and foot units (including
the final static test) without failing is used for this test in accordance with 9.4.2, re-alian it in accordance with
Clauses 10 and 11, 12.2 and 16.1.1 c) and Tables 6, 7 and 8 (see also 16.2.1.1 1). Record the re-use of the
test sample.

Record the test loading level to be applied, together with the corresponding values of the tilting angles yl
and y2 of the foot platform and the test forces Fl and F2,determining the conditions of heel and forefoot
loading. Make specific reference if the additional test loading level P6 specified in Annex C is to be applied.

Record whether a special jig is used.

16.2.1.3 Prepare the test equipment in accordance with 16.1.1 a).

For the test in heel loading, set the tilting angle of the foot platform to n,specified in Table 8.

Record the individual settings for the preparation of the test equipment and the arrangement of the foot
platform for heel loading, including the positioning of the specific heel block.

16.2.1.4 Mount the test sample in the test equipment in accordance with 16.1.1 d).

16.2.1.5 Apply to the heel of the test sample the test force F, and increase it smoothly at a rate of between
100 Nls and 250 Nls to the proof test force Flspof the relevant test loading level, specified in Table 9 or
Table C.2.

*
at the prescribed value for (30 3) s and then decrease the test force F, to zero.
Maintain this force, Flsp,

If the test sample sustains the static heel loading at FlSpfor the prescribed time, record this and proceed
with 16.2.1.7.

If the test sample fails to sustain the static heel loading at FlVwfor the prescribed time, record this together
with the highest value of test force reached or the time for wh~chthe prescribed value of the proof test force,
Figfl has been maintained and decide on the continuation of the test procedure in consideration of the
s ernent given below (but see 16.2.1.11). Record the decision.

The occurrence of failure in the test procedure in one direction of loading prevents compliance with the
performance requirements of this test being claimed for the test sample (see 16.2.3). For this reason the test
shall be terminated, unless otherwise stated in the test submission document or agreed upon between the test
laboratorylfacility and the manufacturerlsubmitter (see 12.3.3).

16.2.1.6 If the test sample fails to satisfy the performance requirement of 16.2.2 in the test procedure of
heel loading, inspect it to detect the nature and, if possible, the location of any damage and record the results.

16.2.1.7 For the test in forefoot loading, set the tilting angle of the foot platform to y2, specified in Table 8.

Ifappropriate, remove the test sample from the test equipment during the setting and arrangement of the foot
platform and subsequently remount it.

Record the individual settings for the arrangement of the foot platform for forefoot loading, including the
positioning of the specific heel Mock.

16.2.1.8 Apply to the forefoot of the test sample that has completed the test procedure of heel loading
without failing (see 16.2.1.5) the test force, F2 and increase it smoothly at a rate of between 100 Nls and
250 Nls to the proof test force F2spof the relevant test loading level, specified in Table 9 or Clause C.2.

Maintain this force, Fzsp,

at the prescribed value for (30 i 3) s and then decrease the test force, F2to zero.
If the test sample sustains the static forefoot loading at FZspfor the prescribed time, record this.

If the test sample fails to sustain the static forefoot loading at F2spfor the prescribed time, record this together
with the highest value of test force reached or the time for which the prescribed value of the proof test
force F~~~has been maintained (but see 16.2.1. II).

16.2.1.9 If the test sample fails to satisfy the performance requirement of 16.2.2 in the test procedure of
forefoot loading, inspect it to detect the nature and, if possible, the location of any damage and record the
results.

16.2.1.10 Decide and record whether or not the test sample has passed the test procedure of heel loading
(16.2.1.4 and 16.2.1.5) and the test procedure of forefoot loading (16.2.1.7 and 16.2.1.8), checking the results
of 16.2.1.5 and 16.2.1.8 against the performance requirement of 16.2.2.

16.2.1.11 If a test sample that has already completed, without failing, the cyclic test procedure for ankle-foot
devices and foot units (see 16.2.1.2) fails to satisfy the performance requirement of 16.2.2 in heel loading
(16.2.1.4 and 16.2.1.5) or in forefoot loading (16.2.1.7 and 16.2.1.8), repeat the complete test (16.2.1.2 to
16.2.1.9) on a substitute test sample and record the failure and the repetition, including all specific records
called for.

16.2.2 Performance requirement

In order to pass the static proof test for ankle-foot devices and foot units, a test sample shall sustain
successive static heel and forefoot loading by the proof test forces Flspand FZspat the prescribed values and
*
inclinations for (30 3) s each.

16.2.3 Compliance conditions

In order to claim that the anklefoot device or foot unit submitted for test according to 9.1 to 9.3 complies with
the performance requirement of the static proof test for anklefoot devices and foot units of this International
Standard according to 16.2.2 at a specific test loading level, tests of this type, each successively applying heel
loading and forefoot loading to the same test sample. shall be passed (in the meaning of 16.2.2) by two test
samples from the prescribed batch, the prescribed batch including the substitute test sample allowed by
16.2.1.I 1 (see 9.3 and Table 12).

Q IS0 2006 -All ftghts reserved

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16.3 Static ultimate strength test

16.3.1 Test method

16.3.1.1 The static ultimate strength tests for ankle-foot devices and foot units shall be conducted on
&*rent test samples, loading the first on the heel and the second on the forefoot, as described in 16.3.1.2 to
16.3.1.14, or vice versa.

A test sample that satisfies the requirements of this test in one direction of loading, may be used for this test in
the other direction of loading (but see 16.3.1.16).

For test samples of lower limb prostheses with material properties andlor construction features which render
them unable to sustain the required ultimate test force at a rate of loading of between 100 Nls and 250 Nls,
specified in 16.3.1.5 and 16.3.1.11, Annex B offers guidance on the application of an alternative static ultimate
strength test, in which a higher rate of loading is applied to the test sample.

The higher rate of loading shall either be specified in the test submission document [see 12.3.4 b)] by the
manufacturerlsubmitter or agreed upon between the manufacturerlsubmitter and the test laboratoryffacility
(see also 16.3.1.5 and 16.3.1.11) and may be applied to the initial test sample or to a substitute test sample, if
the initial test sample has failed at a rate of loading of between 100 Nls and 250 Nls (see 16.3.1.17).

A flowchart for this test is shown in Figure 10.

16.3.1.2 Prepare and align a test sample from the batch specified in Table 12 for this test in accordance
with 9.4, Clause 10 and 11, 12.2 and 16.1.1 c) and Tables 6 , 7 and 8.

If a test sample that has completed the static proof test for ankle-foot devices and foot units without failing is
used for this test in accordance with 9.4.2, re-alian it in accordance with Clauses 10 and 11 and 12.2 and
16.1.1 c) and Tables 6 , 7 and 8 (see also 16.3.1.15). Record the re-use of the test sample.

If a test sample that has completed the cyclic test procedure for ankle-foot devices and foot units (including
the final static test) without failing is used for this test in accordance with 9.4.2, re-alian it in accordance with
(Clauses 10 and 11, and 12.2 and 16.1.1 c) and Tables 6, 7 and 8 ( see also 16.3.1.15). Record the re-use of
the test sample.

Record the test loading level to be applied, together with the corresponding values of the tilting angle y, of the
foot platform and the test force F,, determining the condition of heel loading. Make specific reference if the
additional test loading level P6 specified in Annex C is to be applied.

Record whether a special jig is used.

16.3.1.3 Prepare the test equipment in accordance with 16.1.1 a).

For the test in heel loading, set the tilting angle of the foot platform to y,, specified in Table 8.

Record the individual settings for the preparation of the test equipment and the arrangement of the foot
platform for heel loading, including the positioning of the specific heel block.

16.3.1.4 Mount the test sample in the test equipment in accordance with 16.1.1 d).

16.3.1.5 Apply to the heel of the test sample the test force, F, and increase it smoothly at a rate of
between 100 Nls and 250 Nls until the test sample fails, or the test force, Fl attains the value of the ultimate
test force Fl,, ,pw, leel of the relevant test loading level, specified in Table 9 or Table C.2, without failure of
the test sample.

If appropriate, apply the test force F, at a higher rate of loading, specified by or agreed with the
manufacturerlsubmitterin accordance with Annex B (see 16.3.1).

Q IS0 2006 -All rights reaenred

Record the highest value of the test force F, reached during the test, the rate of loading and whether failure
has occurred. Make specific reference if the test force Fl is to be applied at a higher rate of loading.

If expressly requested by the manufacturerlsubmitter or if requested in the test submission document

[12.3.3 a)], continue the static ultimate strength test after the test sample has withstood the ultimate test force,
F 1 , , u p p , level until failure actually occurs, and record the value of the load at failure.

Take into account that in this case the end attachments used need a higher value of stiffness and ensure that
the values of their deflection and permanent deformation keep within the limits specified in 13.2.2.2.9 at a
higher proof load than is specified in Table 5 or Table C.l for the test loading level to be applied.

16.3.1.6 Check the results of step 16.3.1.5 against the performance requirements of 16.3.2 and record the
findings.

If the test sample completes the test procedure of heel loading without failing, proceed with 16.3.1.a.

Take into account that, according to 8.2 c), a test sample that has passed the test procedure specified in
16.3.1.2 to 16.3.1.5 with step 16.3.1.5 applied at a higher rate of loading in accordance with the altemative
static ultimate strength test specified in Annex 6 (see also 16.3.1.1), subsequently shall pass the static proof
test for ankle-foot devices and foot units specified in 16.2.1 in the relevant direction of loading and at the
relevant test loading level, in order to satisfy the requirements of the altemative static ultimate strength test of
Annex B (see also 16.3.3).

If the test sample fails, decide on the continuation of the test procedure in consideration of the statement given
below (but see 16.3.1.1 5). Record the decision.

The occurrence of failure in the test procedure in one direction of loading prevents compliance with the
performance requirements of this test being claimed for the test sample (see 16.3.3). For this reason the test
shall be terminated, unless otherwise stated in the test submission document or agreed between the test
laboratorytfacility and the manufacturerlsubmitter (see 12.3.3).

16.3.1.7 If the test sample fails to satisfy the performance requirement of 16.3.2 in the test procedure of
heel loading, inspect it to detect the nature and, if possible, the location of any damage and record the results.

16.3.1.8 Prepare and align a fresh test sample from the batch specified in Table 12 for this test in
accordance with 9.4, Clauses 10 and 11, 12.2 and 16.1.1 c) and Tables6, 7 and 8 (but see 16.3.1.1 and
16.3.1.16).

If a test sample that has completed the static proof test for ankle-foot devices and foot units without failing is
used for this test in accordance with 9.4.2, re-alian it in accordance with Clauses 10 and 11, 12.2 and
16.1.1 c) and Tables 6,7 and 8 (see also 16.3.1.15). Record the re-use of the test sample.

If a test sample that has completed the cyclic test procedure for ankle-foot devices and foot units (including
the final static test) without failing is used for this test in accordance with 9.4.2, re-alian it in accordance with
Clauses 10 and 11, 12.2 and 16.1.1 c) and Tables 6, 7 and 8 (see also 16.3.1.15). Record the re-use of the
test sample.

Record the test loading level to be applied, together with the corresponding values of the tilting angle, of the
foot platform and the test force, F2, determining the condition of forefoot loading. Make specific reference if the
additional test loading level P6 specified in Annex C is to be applied.

Record whether a special jig is used.

16.3.1.9 For the test in forefoot loading, set the tilting angle of the foot platform to n,specified in Table 8.
Record the individual settings for the arrangement of the foot platform for forefoot loading, including the
positioning of the specific heel block.

16.3.1.10 Mount the test sample in the test equipment in accordance with 16.1.1 d).
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 w heel (H) or forefoot (F) loading

i
Settings and adjustments for
heel (H) or forefoot (F) loading 11
OPTION
Repetition of heel (H) or
forefoot (F) loading on
substitute test sample at
-
(H) 16.3.1.2 to (F) 16.3.1.8 to increased rate of loading
16.3.1.4 16.3.1.10 (H) 16.3.1 .I7 (F) 16.3.1.17
-
Heel (H) or forefoot (F) loading Repetition of heel (H) or
to ultimate load level at normal forefoot (F) loading on
or increased rate of loading substitute test sample at normal
or increased rate of loadinn -
I
(H) 16.3.1.5
I (F) 6.3.1.1
(H) 16.3.1.15 (F) 16.3.1.15116
Yes

A Loading .I. A Has test sam~le

Yes

Applied rate

A 1 Increased
of loading?
Application of separate
static proof test (16.2.1) I I
Proof test
requirements
satisfied?
(H) 16.3.1.6

or forefoot (F) loading of or forefoot (F) loading of

static ultimate strength test for static ultimate strength test for
ankle-foot devices and foot units ankle-foot devices and faot units
(H) 16.3.1.6 (F) 16.3.1.12 (H) 16.3.1.6 (F) 16.3.1.12

Figure 10 - Flowchart for the static ultimate strength test specified in 16.3.1

Q IS0 2006 -All rights reserved

IS0 22675:2006(E)

16.4 Cyclic test

16.4.1 Test method

16.4.1.1 The cyclic test for ankle-foot devices and foot units shall be conducted on a test sample,
continuously loading on the foot from heel contact to toe-off by repeated application of synchronized profiles of
tilting angle and test force, followed by final static loading on the heel and the forefoot, as described in
16.4.1.3 to 16.4.1.12.

A flowchart for this test is shown in Figures 1 1 and 12.

16.4.1.2 The following requirements shall apply.

a) During the course of the cyclic test, specified parts shall be replaced when the number of cycles has
reached a value at which such replacement is indicated in accordance with the manufacturer's/submitter's
service instructions andlor the test submission document [see 12.3.5 b)]. All such replacements shall be
recorded.

b) A test sample that completes the cyclic test without failing shall be subjected to final static heel and
forefoot loading by the test forces Ftfinand F2fin,successively applied at a rate of between 100 Nls
*
and 250 Nls and maintained for (30 3) s for each loading case, with the foot platform set at the tilting
angle, y, for heel loading and y2 for forefoot loading.

c) A test sample that fails andlor a test sample that completes the cyclic test without failing shall, at the
request of the manufacturer/submitter, be visually examined at the magnification specified in the test
submission document [see 12.3.5c)], and the presence, location and nature of any fractures
andlor cracks recorded, together with the magnification used.

16.4.1.3 Prepare and align a test sample from the batch specified in Table 12 for this test in accordance
with 9.4, Clauses 10 and 1 1 , 12.2 and 16.1 .I
c) and Tables 6 , 7 and 8.

Record the test loading level to be applied, together with the corresponding profiles of the tilting angle At) of
the osdllating foot platfotm and the pulsating test force Fc(t) or F c ( ~determining
, the loading conditions at
each instant of the loading cycle, and the prescribed number of cycles. Make specific reference if the
additional test loading level P6 specified in Annex C is to be applied.

Record Wether a special jig is used.

16.4.1.4 Prepare the test equipment in accordance with 16.1.1 b).

Record the individual settings for the preparation of the test equipment and the arrangement of the foot
platform, including the positioning of the specific heel block.

16.4.1.5 Mount the test sample in the test equipment in accordance with 16.1.1 d).

Arrange and adjust the means to resist dislocation of the test sample during its lift-off phase in accordance
with 16.1.1 e).

Record the individual settings.

16.4.1.6 Successively apply static heel loading as specified in a) and static forefoot loading as
specified in b).

a) For static heel loading, set the tilting angle of the foot platform to y,, specified in Table 8, and apply to the
heel of the test sample the maximum test force F,,,, specified in Table 9 or Table C.2.

b) For static M o o t loading, set the tilting angle of the foot platform to a,specified in Table 8, and apply to
the forefoot of the test sample the maximum test force F,,,, specified in Table 9 or Table C.2.
If the test sample sustains the successive static heel and forefoot loading at
,,,F
, and F2cmax,
proceed
with 16.4.1.7.

If the test sample fails to sustain the successive static heel and forefoot loading at Fianaxand F2max, record
this together with the highest value of test force reached in each direction of loading and terminate the test.

16.4.1.7 Apply to the test sample simultaneously, the profiles of the tilting angle At) of the oscillating foot
platform and the pulsating test force Fc(r) or Fc(d in accordance with the requirements of 13.4.2 and the
values for the relevant test loading level, specified in Tables 8 to 11 and C.2, at a frequency of between 0,5 Hz
and 3 Hz in accordance with the test submission document [see 12.3.5 a)] for a series of cycles, to allow the
test sample and the test equipment to 'settle down".

NOTE I The number of cycles required for the test to settle down will depend on the nature of the test sample and the
test equipment control mechanism.

Start at any appropriate instant of the loading cycle.

Take care that during this settling-in period the highest force applied to the test sample does not exceed the
maximum test force
, , ,F by more than 10 % (see 13.4.2.12).

NOTE 2 Experience has shown that the repeated loading at values exceeding the maximum test force F,,, by more
than 10 % can cause an early deterioration of the test sample.

Do not proceed with 16.4.1.8 until the test sample and the test equipment have settled down, and the profiles
of the test force Fc(t) or FC(dand the tilting angle At) of the oscillating foot platform have achieved the
waveform specified in 13.4.2.10 and keep within the tolerances specified in 14.3 f), g) and h).

Record the frequency called for, together with the number of cycles required to settle down and whether the
pulsating test force Fc(r) or FC(d and the tilting angle At) of the oscillating foot platform are applied in
accordance with 13.4.2.10 and 14.3 9, g) and h).

If the frequency called for cannot be achieved, or does not allow the pulsating test force Fc(t) or Fc(d and the
tilting angle At) of the oscillating foot platform to be applied as specified, repeat the preceding steps of this
subclause at a different frequency, preferably between 0,5 Hz and 3 Hz, to be agreed upon between the test
laboratoryffacility and the manufacturerlsubmitter.

Record any agreement on a frequency differing from the value called for

If the pulsating test force F,(t) or Fc(d andlor the tilting angle At) of the oscillating foot platform cannot be
applied at any frequency agreed upon between the test laboratorytfacility and the manufacturerlsubmiier,
record this and terminate the test.

16.4.1.8 Apply to the test sample, simultaneously, the profiles of the tilting angle fir) of the oscillating foot
platform and the pulsating test force Fc(t) or Fc(d in accordance with the requirements of 13.4.2 and the
values for the relevant test loading level, specified in Tables 8 to 11 and C.2, at a frequency of between 0,5 Hz
and 3 Hz in accordance with the test submission document [see 12.3.5 a)] or any agreement on a frequency
diering from the value called for therein, preferably between 0,5 Hz and 3 Hz (see 16.4.1.7), for the
prescribed number of cycles specified in Table 9 or Table C.2.

Inspect the waveforms of the applied test force Fc(t) or FC(dand the tilting angle At) of the oscillating foot
platform. Terminate the test if the waveforms do not comply with 13.4.2.10.

Record the frequency applied, together with the results of the inspection of the waveform and the decision on
the continuation of the test.

16.4.1.9 During the course of the cyclic test, replace any parts which would be replaced in normal senrice.
Proceed as follows.

Q IS0 2006 -All rights reserved

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(3)900z:s~9ZzOSI
16.4.3 Compliance conditions

In order to claim that the ankle-foot device or foot unit submitted for test according to 9.1 to 9.3 complies with
the performance requirements of the cyclic test for ankle-foot devices and foot units of this International
Standard according to 16.4.2 at a specific test loading level, tests of this type shall be passed (in the meaning
of 16.4.2) by two test samples from the prescribed batch (see 9.3 and Table 12).
 (e Z'V-9c 4 s ! w IOU
saop aldwes I s q =u!s
quawsn!pe pue
(3)900z:s~9zz
OSI
 Start of "regular" cyclic
loading (progressive loading
from heel contact to W f f )

16.4.1.8
4
Waveforms
of F(t) and y(t) since waveforms of
F(t) andlor y ( t ) do not
16.4.1.8
Yes

Continuation of test until

shutdown of test equipment
because of Idue to
a) replacement of parts
b) occurrence of failure
c) completion of cyclic test
16.4.1.9/16.4.1.10

Replacement - b) - F ~
Occurrence
of parts of failure
16.4.1.9 16.4.1.10
c)
1
Completion of
cydic test
16.4.1.10

Final static test at

16.4.1 .I
1

cyclic test for ankle-foot cyclic test for ankle-foot

devices and foot units devices and foot units
16.4.1.12 16.4.1.12
Figure 12 - Flowchartfor the cyclic test specified in 16.4.1
Continued from Figure 11
17 Test laboratorylfacilitylog

17.1 General requirements

17.1.1 The test laboratorylfacility carrying out the tests specified in this International Standard and indicated
in the test submission document shall ensure that all records called for in this lnternational Sstandard are
entered in the test laboratorylfacility log.

171.2 The submitter of test samples and the identification of the test submission document shall be clearly
indicated and the date or dates of receipt be recorded.

17.1.3 The identification of the test report or reports (such as serial number) shall be clearly indicated and
the dates of preparation and submission be recorded.

17.2 Specific requirements

According to the instructions of this lnternational Standard (see NOTE), spec if^^ records shall be entered in
the test laboratorylfacility log for

a) the identification (number) of the test equipment used and the reference (number) of the end
attachments, jig and measuring devices (if used),

b) the selection, type, preparation, identification and alignment of test samples,

c) the conduct of specific tests, selected in accordance with this lnternational Standard and the test
submission document and

d) any unusual features observed during the test(s).

NOTE Detailed instructions on records to be entered in the test laboratory/facilitylog are given in the relevant clauses
of this International Standard.
In addin, Annex D offers a summary of these records for general informaton and guidance of test laboratorylfadltty staff
and submitters (see 18.3).

18 Test report

18.1 General requirements

18.1.1 The test laboratorylfacility shall prepare a test report for the test(s) conducted and shall provide at
least one copy to the submitter of the test sample.

NOTE The test laboratorylfacilii should maintain another copy of the test report with the test log. This will simplify
the reply to possible further inquiries of the manufadurerlsubmitter.

18.1.2 The test report shall be signed and dated on behalf of the test laboratorylfacility by a designated
person.

18.1.3 The test laboratorylfacility shall clearly indicate a name and address for communication.

18.1.4 The test laboratory/facility shall provide a unique and traceable identification and date for the test
report (such as serial number), including identification of each page and the total number of pages of the
mport. The test laboratorylfacility shall maintain a record of such identificationand date.

18.1.5 The submitter of the test sample, the manufacturer, if know, and the test laboratorylfacili
identification shall be clearly indicated.

8 IS0 2006 -All rights resenred

18.1.6 The date of receipt of test samples and date(s) of preparation of the test report shall be clearly
indicated.

18.2 Specific requirements

18.2.1 For each type of test conducted (see 9.3), the test report shall specifically refer to this International
Standard, the clauses related to the specific type of test performed, and the test loading condition or direction
of loading, the test loading level applied and which special test set-ups were used. This particularly applies to
tests that are conducted at the additional test loading level P6 according to Annex C (see 16.2.1.2, 16.3.1.2
and 16.4.1.3), and to the alternative static ultimate strength test according to Annex B (see 16.3.1.1, 16.3.1.5
and 16.3.1.11).

18.2.2 For each ankle-foot device or foot unit for which an appropriate batch or batches of test samples have
been submitted for test, the test report shall state the tests in which compliance with requirements of this
International Standard has been demonstrated. The test report shall also state the tests conducted, in which
compliance has not been demonstrated.

18.3 Options
18.3.1 The test report shall include any additional information, specifically requested in the test submission
document (see 12.1.2).

18.3.2 Upon request of the submitter, the test laboratoryffacility shall copy from the test log to the test report
any further records of samples and test results called for. Annex D gives details of the records which shall be
entered in the test laboratoryffacilii log.

19 Classification and designation

19.1 General
A prosthetic ankle-foot device or foot unit

a) for which compliance with the requirements of this International Standard is claimed (see 9.1 and 9.2) for
a specific test loading level 'Pa (see 7.2) and

b) which is suitable for lower limb amputees with a body mass not exceeding a specific value of maximum
body mass, 'ma kg according to the manufacturer's written instructions on the intended use of that device,

shall be classified and designated as shown below.

- -
IS0 22676 "P" "m" kg

19.2 Examples of classification and designation

EXAMPLES 1 to 3 illustrate variations of classification/designation for ankle-foot devices or foot units that
comply with the requirements of IS0 22675 for one and the same test loading level (P4).

These examples are distinguished by diierent values of maximum body mass (70 kg, 80 kg, 90 kg), which
indicate differences in the intended use of the devices concerned, depending on their individual design.

EXAMPLE 1 - -
IS0 22675 P4 70 kg

EXAMPLE 2 IS0 22676 - P4 - 80 kg

EXAMPLE 3 IS0 22676 - P4 - 80 kg

-
Q IS0 2006 All rights reserved
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 Annex A
(informative)

Reference data for the specification of the test loading conditions

and test loading levels of this International Standard

I A.l Background statement

The test loading levels P5, P4 and P3 according to 7.2 of this lntemational Standard correspond to the test
loading levels P5, P4 and P3 according to 7.2 of IS0 10328:2006. These are based on data acquired at the
time of development of IS0 10328:1996, measured on lower limb prostheses of the types used at that time
and listed according to the body mass of the amputees whose locomotion was measured. The data used
comprised information presented at the Philadelphia meeting in 1977 and additional data subsequently
contributed by several countries.

The test loading level P5 is based on data from all amputees including a few whose body mass
I exceeded 100 kg. The test loading levels P4 and P3 are based on locomotion data from amputees whose
1i body mass is less than 80 kg and 60 kg, respectively.

I For the proposed additional test loading level P6 see Annex C.

The method of classinglrelating the test loading levels withlto specific ranges of body mass of amputees on
whose locomotion data these are based should, however, not obscure the fact that these locomotion data are
also determined by the influence of all other factors, on which the loads developed in a prosthesis during use
depend (see NOTE I ) but only within the range that was possible with respect to the lifestyle and activity level
of the amputees and the performance of the ankle-foot devices and foot units available at the time of data
acquisition (see NOTE 2). All of these factors should therefore be taken into account together with the body
mass, Wen specifying the conditions of use of a specific ankle-foot device or foot unit that complies with the
requirementsof this lntemational Standard for a specjfic test loading level [see 5.2 b)].

NOTE I Besides the general physical parameters and locomotion characteristics of the amputee already addressed
in 7.2.1, other specific factors on which the loads developed in a prosthesis during use depend are the individual character
of use of the prosthesis by the amputee, determined by herlhis lifestyle and adivity level, the performance of the
pmthesis provided by the mechanical characteristics of the components and their prosthetic assembly and alignment,
occasional events such as, for example, tripping or stumbling, and environmental conditions in which the prostksis will be
used.
NOTE 2 The range of influence of these factors may change in course of time, due to changes in the lifestyle and
activity level of amputees and improvements in the performance of ankle-foot devices and foot units.

A.2 Specification of the test loading conditions for the different test loading levels
A.2.1 General
Although the concept of the tests on ankle-foot devices and foot units of this International Standard differs
from that of the corresponding tests of IS0 10328, the relevant values of loads and dimensions are adopted
I where possible. Nevertheless, a few adaptatiis are unavoidable.

These and other matters relevant to the specitication of the test loading conditions and test loading levels of
this lntemational Standard are dealt with in detail in ISOITR 22676 thus enabling the volume of this
International Standard to be confined to only indispensible information. (For further information see Annex E
and Bibliography.)

I A.2.2 to A.2.4 present information on selected items, presented as extracts and summaries from
lSO/TR 22676.

O IS0 2006 -All rights reserved 63

A.2.2 Directions of static and maximum cyclic heel and forefoot reference loading
NOTE For the meaning of 'reference" see also statements under 'IMPORTANT" at the end of A.2.4.1 and A.2.4.2.

A.2.2.1 Basic relationships and conditions

The specification of the directions of static and maximum cyclic heel and forefoot reference loading is based
on the relationships of a) and the conditions of b) to d).

a) According to Figure A.l (p. 69), for any instant of loading there is a given relationship between the test
force, F and the forces at the foot platform, comprising the tangential (A-P) force component, FF the
perpendicular force component, Fp and their resultant, FR. This relationship is determined by the angles
4 Band Y.

The following equations apply:

p = arctan (FTIFP) (A.2)

b) The values of the tilting angles y, and of the foot platform for static and maximum cydic heel and
forefoot reference loading are consistent with those specified in IS0 10328 for the separate struchrral
tests on ankle-foot devices and foot units. These values are fi = - 15" for heel loading and a = 20" for
forefoot loading (see Table 10, Figure 7 and subclause 17.2 of IS0 10328:2006 and Table 8 of this
International Standard).

c) The ratio FTIFpof the values of the tangential and the perpendicular force components at the foot platform
according to Figure A.1 for static and maximum cyclic heel and forefoot reference loading at the tilting
angles according to b) is roughly f 0,15.

NOTE This ratio is based on gait analysis data representative of normal level walking.

d) The offsetsfAl and& of the ankle load reference points PAl and P, (see 6.3 and Figure I ) relevant to
heel and forefoot load~ngon an ankle-foot device or foot unit of foot length L = 26 cm are consistent with
those specified in IS0 10328:2006 for the ankle load reference points PA( and PAll of test loading
conditions I and II for test loading level P5. These are fAl = - 32 mm andfAll = 120 mm (see Table 6 of
IS0 10328:2006).

A.2.2.2 Lines of action of the resultant reference forms FR1and FR2

The relationships of A.2.2.1 a) and the conditions of A.2.2.1 b) and c) allow the inclination of the lines of action
of the resultant reference forces FR1and Fw of static and maximum cyclic heel and forefoot reference loading
to be specified as follows:
- From equation (A.2) and the condition according to A.2.2.1 c) p = arctan (FTIFp) = arctan ( f 0,15) =
f 8,5'.

- From equation (A.l) and the condiions according to A.2.2.1 b) a, = fi - = - 15" + 8,5" = - 6,5" and
a2=y2-&=20°-8,5"= 11,5".

Approaching these thresholds as far as possible in consideration of further aspects to be noted, the directions
of static and maximum cyclic heel and forefoot reference loading on an ankle-foot device or foot unit of foot
length L = 26 crn can be specified as fdlows:
- the direction of static and maximum cyclicheel reference loading is defined by a straight line which
passes through the ankle reference point PA, specified in A.2.2.1 d) and is inclined to the teaxis by
al = - 6,18O;
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'lanal6u!pw lsa) aw 40 )uapuadapu! ')oo~jo saqs I(eo) hldde
4uuogun lleqs u w o d o ~ ds!y 'plepucr)~leuo!)ewa)ul s!q 40 sgun $004 pue swpap too)-aplue J O ~qsa) w
40 ) d m qseq aw 0) 6u!p~033v'al6ueu) WuaJaiar e 40 u o ~ o d o ~ aq)
d au!uuajap 'um gz = 7 @uq 40 ) o o ~
a* 40 juyd etg pue a6pa laaq muaasod arl) w ~ a ~ a 6 'a o ) l d )u!od uop!ldde peal do) a q )o ~ o aql d
:Jauuew 6ugwollo~a q u! 7 M u a l JWa q uo Id p y d
uogeqldde peol do) aq) 40 uoysod aqq 40 a~uapuadape saqs!lqe)sa s!ql '7 @uq $004 aq) 01 ~'euowodoId
s! Jeut 6u!1=s e ~ o q q
s pawdxa aq u= :,aswVJasayl '~OOZ:QL~ZZ WOSI 40 c-z'c u! pa~1)suouraps! w
a ~~(yn
- a d pue L V d s)u!od auaJajaJ peol alyue pajelaJ aqljo :,a~#o-~Jaq) uo 6u!puadap ' ~ u a ~ aq p
l ' l n pue 1 'Ysa~eu!pxmaql Aq pau!uuaaap 'ld lupd uog=!~dde peo~do) 40 uomod aw )nq ( 3 1 0 ~aw)
awes q aq lly b pue LD sa16ue aw Aq pau!uuawp uogeu!pu! J!aw '7 s@ual )w Jatgo squn lool
JO saqnap Iooj-alyue uo 6u!peol WuaJajaJ joojaJo4 pue laaq 3!13A3 wnur!xew pue ~ n e l 40 s uo!)De 40 sauy mj
!6ca689+/80'9 - = (na IZnpUe E9'sLE +Eel6 = (n* "n
1
I
ale m,g pue sa3~04muaJajw tumlnsaJ a q p uo!pe 40 sau!l a q 40 suo.wuy aqj -
:sUnsaJ 6upwollo4 aql sapwo~dpoqaw s!qa 'ungz = 7 q16ualpoj 40 qun loo4 JO aqnap ioo4iqyue ue ~ o j
.V)zn = V)ln 6u!~ndhq uo!)msJalu! 40 )u!od J!aw 6u!u!uua)ap uaq) pue
(E'v) uo!)enba w o ~uo!pe
j jo sau!l asaqljo 0 % pue (nrn s u o ~ u t y
a q l a g je 6u!u!uuatap Aq pa)elnqw aJe l d ju!od uoneqldde peol do) aq) 40 pue 1J sa)eu!pJm a q l
' Z ' Z - Z ~u! payaads 6u!peo( WuaJaJaJ)oojaJoj pue laaq 3!13r(:, wnw!xew pue q e l s p a d pue
1% s a ~ a3uaJajaJ
q JuqlnsaJaw 40 uog3e 40 saw1 a q 40 uo!pauatu! 40 ju!od a q s! (1a~n6!jpue 8.9 aas) l d
)u!od uogeqdde peal do) aq) 'plepuets IeuogeuJqul s!w 40 sgun 100) pue smyap w4-alyue uo sjsa) aw ~ o j
'0PL'l.L =
Aq s!xe-n aq) o) pau!pu! s! pue (p 1.z.z'~u! paypads 'md ju!od a3uaJajaJ alyue aqj q6no~q)sassed
l s
43!14~au!l W~!~JISe Aq paugap s! 6u!peol a3uaJaJaJ)oolaJo) DAD wnwjxew pue ~ ~ ~40euon=~!p aql -
(3)900Z:9~
9zz OSI
 inclinations of the lines of action of the resultant reference forces FR1and FR2and, hence, fixed values of the angles a,
and a,determining the indinations.

A.2.3 Magnitudes of static and maximum cyclic heel and forefoot reference loading
The specification of the magnitudes of static and maximum cyclic heel and forefoot reference loading is based
on the following general condition.

The specific values FRlxand FR2,of the resultant reference forces FRl and Fw according to this International
Standard (see Figure A.l) are consistent with the corresponding values Flx and F2, of the test forces Fl and
F2spee
cifid in IS0 10328:2006 for the separate tests on ankle-foot devices and foot units (see Tables 11 and
D.3 of IS0 10328:2006). The specific values FRlxand FR2x of the resultant reference forces FR1 and Fw are
listed in Table A. 1.

I
The specific values FlXand FZx of the test forces Fl and F2related to the specific values FRlxand Fwxof the
resultant reference forces FR1and FR2(see Figure A.l) are determined by the following equation, derived
I from the relationship described in A.2.2.1 a):
i 2,= F ~ l ~2
, x al, 2 (A.5)
i! Fl COS

The specific values FIX and F2xof the test forces Fl and F2calculated using equation (A.5) for a-,= - 6,18"
i:
II
and = 11,14° (see A.2.2.2) are listed in Tables 9 and C.2.

Table A.1 - Magnitudesof resultant referenceforces FRlxand Fwx

Related test forces FIXand Fa of the separate tests on ankle-foot devices and foot units
specified in IS0 10328
Resultant reference (see Tables 11 and D.3 of IS0 10328:2006)
forces FRlxand Numerical values for heel and forefoot loading FlXand Fa at test loading
F,, of static and levei Py
maximum cyclic
heel and fodoot Smh, P8 PS P4 P3
refemnee loading
Heel Forefoot Heel Forefoot Heel Forefoot Heel Forefoot
N

F~irp Fly$ 2800 - 2240 - 2065 - 1610 -

Fm F~
- 2800 - 2240 - 2065 - 1610
F ~ i al o. w ~ r k v d F l w , k a w ~ 4200
~
- 3360 - 3098 - 2415 -
F~k-bvd F ~ . ~ a n s r ~
- 4200 - 3360 - 3098 - 2 415
F ~ l r uupper
, kval F l r u , u p p w ~ ~5600
- 4480 - 4130 - 3220 -
- F ~up. pa^ Fa.
up par^
- 5600 - 4480 - 4130 - 3 220

F~lcmex Flat 1600 - 1280 - 1180 - 920 -

Fm F2m
- 1600 - 1 280 - 1180 - 920
F~llkr Flfin- 2800 - 2240 - 2065 - 1610 -
k i n Fan
- 2800 - 2240 - 2065 - 1 610

Q IS0 2008 -All rights reserved

 A.2.4 Reference test loading conditions of static and cyclic tests

A.2.4.1 Static tests

According to the statements of A.2.2 and A.2.3, the reference test loading conditions for static (and maximum
cyclic, see NOTE) heel and forefoot loading according to this International Standard are determined by the
parameters listed in a) to d). For the meaning of "reference" see "IMPORTANT".

a) The position of the top load application point PT (= point of intersection Pi of the lines of action of the
resultant reference forces FR1and ,)F , determined by the coordinates fT and uT relevant to the foot
length L of the test sample (see A.2.2.3). These are specified as offsetsfT, and uT, in Table 7.

b) The direction of the lines of action of the resultant reference forces FRl and, ,F determined by the
coordinates of the top load application point PT[see a)] and their inclinations to the u-axis, determined by
the angles al = - 6,18" and % = 11,14" (see A.2.2.2).

c) The magnitudes of the resultant reference forces FRl and, ,F specified in Table A. I,and the related test
forces F1and F2to be applied in the top load appl~cationpoint PT [see a)] as illustrated in Fgure A.1,
determined by equation (A.5) for al = - 6,18" and a2 = 11,14°. These are specified in Table 9.

,I d) The tilting angles yl = - 15" and y2 = 20" of the foot platform for static (and maximum cyclic) heel and
forefoot loading. These are specified in Table 8.

-
IMPORTANT The inclinations of the lines of action of the resultant reference forces FR1 and FR2 to
the u-axis addressed in b) are only relevant to the reference test loading conditions of the static (and
I
-
cyclic see NOTE) tests, since the concept of this International Standard allows each sample of
ankle-foot device or foot unit to develop its individual performance under load corresponding to its
individual design.

This will automatically determine the individual position of the bottom load application point PBl on the heel or
PB,.on the forefoot of the test sample (and with it the individual inclination of the load line) relatlng to the tilting
position of the foot platform at yl or a [see d)] and the individual magnitude of the resultant force FR1 or FR2.
For this reason the configuration of the test set-up for the preparation of test loading [see 16.1.Ia)] is
determined only by the position of the top load application point PT relevant to the foot length L of the test
sample according to a) and the tilting angles y., and & of the foot platform according to d).

NOTE References (in parentheses) to the cydic tests take into account that the linear and angular dimensions
determining the reference test loading condiions for static heel and forefoot loading are identical to those determining the
1 reference test loading conditions for maximum cydic heel and forefoot loading [see A.2.4.2 a)].

A.ZA.2 Cyclic test

According to the statements of A.2.2 and A.2.3, the reference test loading conditions for cyclic loading
according to this International Standard are determined by the parameters listed in a) and b). - [For the
meaning of 'reference" in a) see IMPORTANT of A.2.4.1 and for the meaning of 'reference" in b) see
IMPORTANT of this subclause.]

a) The reference test loading conditions for maximum cydic heel and forefoot loading are determined by the
same linear and angular dimensions as the reference test loading conditions for static heel and forefoot
loading (see A.2.4.1).

b) The reference test loading conditions for repeated foot loading proaressinq from heel contact to toe-off
are determined by the parameters listed in 1) to 4).

1) The position of the top load application point PT [see A.2.4.1 a)].

2) The progression of the resultant force FRtcharacterized by the sequence of the instantaneous
directions of its line of action, which are determined by the coordinates of the top load application

8ISO2006-AllrigMsreserved 67
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' 6 ' z ' v ' ~ ~ )(v)
o uo~enbaAq osle pue 1L pue 01, salqel pue g an6!j
u! ua~!6s! d aoJo4 )sal ayl 40 aly0~da g 40 uo!)eoy!sds pue uogduasap aq) uo aauep!n6 JalRJnj
alqel u! pa~pads'(alyo~d6u!peol p urnw!xeur puz) * w z j pue
(alu0Jd 6u!peol 40 wnw!u!w a)e!pauua)u!) U!LU3d '(alyo~d6u!peol p wnw!xew j s ~ )xemLd sanlen
aq) uo paseq Aluew!Jd s! JO (I)% a3104 pa) aq) 40 a(goJd ayl 40 uogwypads pue uo!)duasap a y l
v)=.
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)
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sanleA snoauquqsu! a q l .L j u! pa)e4snll! se 44)'~ uuogeld 1004 aqt 40 a16ue6u!)lg 40 uowury
e JO g a~n6!ju! pa)e4sn((! se (1)'~ awg p uovury e se L'V a~n6!ju! pa)wJsnll! se [(e C'P'Z'Vaas]
)u!od uo!)w!ldde peol do) aq) u! paydde aq 0) '=d am04 )sa) 6ugeslnd ay) 40 (aluna) alyo~da y l (g
.(c'v a~n6!jaas) x, a16uep sanleA snoauque)su!
pajelaJ aql le s!xe-n aqj 01 uogae 40 au!l aq) 40 suo!)eu!pu! aqq pue [(e L'P'Z'V aas] )u!od
(3)9002:9~92~
OSI I
1)
 ur~weldPo)40 a16ue6 ~ A~ 9
ddPdqjw fh!u!ur~appddwauodum aaq pue Mdmqjuwnsar uaam)eq q6ua B
=wtuwnsa 40 u w w 40 +I lo a(&re uo!wuw!
l
a ~ l ~Id
uualleld $004ol imua&te) ) u ~ o d w
lUO#qd )OOj 0) ~elIW!pudJed )ueuodum dd
eao~~u~ns Md
e,
d a 0 4 pal )o uo!p!ldde 40 au!l oj WaAsuq )uauodw earql Hd
-0llsat d
)u!od uo!)m!idde peq do)
w j s k a)eu!prw lo saxe n '/
urJqUe@tocy L
Aen
(3)900z:s~9zzOSI
 Dimensions in millirnetres

Key
1 symbolic view of foot
f , a axes of coordinate system
+ effediv6 knee-joint centre
CA e W v e anklejoint centre
top bad application points relevant to indicated foot length L (Reference: P,, ,for L = 26 an).
Flgur, A2 -Illustration of the dependence of the porlon of the top load application point PTon the
foot length L - (see A.2.2.3)

Q IS0 2006 -All fights reserved

 Annex B
(informative)

Guidance on the application of an alternative static ultimate strength test

1 B.l Background statement

Due to the characteristics of most non-metallic materials used in lower limb prostheses, the rate of loading of
between 100 Nls and 250 Nls, specified in 16.3.1.5 and 16.3.1.11 for the static ultimate strength test, may be
too low.

1 To address this, an alternative static ultimate strength test is proposed in this annex, which applies higher
I rates of loading to be specified by the manufacturerlsubmitter of the sample under test. (Rates of between
1 kNls and 5 kNls are considered to be appropriate.)

This alternative static ultimate strength test is intended to be applied to samples with material properties
andlor construction features which render them unable to sustain the required ultimate test force at a rate of
loading specified for the standard static ultimate strength test previously referred to (e.g. structural members
manufacturedfrom materials subject to significant creep).

If the static ultimate strength test specified in 16.3.1 is conducted at a rate of loading higher than 250 Nls, the
procedure includes the application of the static proof test specified in 16.2.1 and thus, if the required number
of test samples from the prescribed batch complies with the performance requirements as specified in 16.3.2,
additional static proof tests are unnecessary.

NOTE This altemative static ultimate strength test was first developed for the principal structural tests and the
separate structural tests on ankle-foot devices and foot units of IS0 10328:2006. It has been adopted for the purposes of
the static ultimate strength test of this International Standard.

B.2 Test procedure

a) Carry out steps 16.3.1.2 to 16.3.1.4 (16.3.1.8 to 16.3.1.lo) of the static ultimate strength test.

I b) Proceed with 16.3.1.5 (16.3.1.11) in the alternative way addressed therein and increase the test
force F, (F2) at the higher rate specified in the test submission document [see 12.3.4 b)] by the
manufacturerlsubmitter of the test sample under test until the test sample fails, or the test force Fl (F2)
attains the value of the ultimate test force Flsu, upper level (F2su, upper without failure of the test
sample.

Record the rate of loading and the highest value of the test force Fl (F2) reached during the test and
whether failure has occurred.

c) If the test sample satisfies the performance requirements specified in 16.3.2, subject it to the static proof
test specifled in 16.2.1.1 and record the results.

d) To claim compliance with 16.3.3 and this annex 8, the condition addressed in 16.3.3 b) shall be met.
Record whether or not the test sample meets this condition.
 Annex C
(informative)

Guidance on the application of an additional test loading level P6

C.l Background statement

Field experience has shown that there is a need for lower limb prostheses which sustain loads above the level
covered by test loading level P5.

In order to allow the structural testing of such prostheses on a uniform basis, an additional test loading
level, P6, is proposed in this annex. Additional test loading level P6 is derived from data acquired from
measurements and testing of existing products in service. As an interim measure, pending validation, it is
suggested that the test loading conditions specified in C.3 are appropriate.

NOTE Additional test loading level P6 was fitst developed for the principal structural tests and the separate structural
tests on ankle-foot devices and foot units of IS0 10328:2006. It has been adopted for the purposes of the static and cydic
tests of this International Standard.

C.2 Test forces of the proof test of end attachments

The test forces of the proof test of end attachments shall be as specified in Table C.l

C.3 Test loading conditions

a) The test dimensions shall be as specified in Tables 6 ' 7 and 8.

b) The test forces and the prescribed number of cycles shall be as specified in Table C.2.

Table C.l -Test forces of the proof bst of end attachments for test loading level P6 (see 13.2.2.1)
End attachments for Stabilizing Settling test Proof test
1
test foate, force, F&; fme,
Test loading condition
Fua; (F-1 (FM) b Fw; (FRpe)
Ted procedure Heel ioadlng Fomfoot loading
F, at y = - 15" F, at y = 20" N N N

1 273; (1 280) 6 681; (6 720)

All tests a 50
1 256; (1 280) 6 593; (6 720)
a
a%urn-
End attachments that satisfy the stiffness requirements of the proof test of end attachments for proof test force
of test loading level P8 specibd in this table are suitable for the static and cydic tests of this International
out at test loading level P6 and at a#kwer levels.
For wts of end aiWchmnts, individually de&gned to the spedfic requirementsof the test W n g conditions of the stab and cydic
tests of this International Standard andlor to the specific requirements of the ankle-foot devices or foot units submitted for test,
particular conditions may apply (see the OPTION desaibed in 13.22.1).
b The relationship between the values of F and F, (placed in parentheses) is determined by equation (A.5). using the values of a,
ond + spedfied in A.2.3. The values o? F, are calculated from the relevant values listed in Table A.l (see A.2.3), using the
fedom spedfied in Tabla 3. Which set of values applies depends on how the assembly of end attachments k placed in the test
equipment (see 13.2.2.2.3).

a IS0 2008 -All rights resenred

 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)

Test loading condition

Unlt
Test procedure and test force Heel loading, F I X Heel loading, F,,

Flw 2 784 -
$
u
Static proof test force N
-
0) F2=w 2 747
U

g F~w
h ,x ~ l d 4 176 -
C N
-
P Fzw, lower level 4 121
-
U
Static ultimate test force
5 567 -
5 Fl,, upper hel
N
V)
F a , upper level
- 5 494
1st maximum value of pulsating
test force Fl- N 1 591 -
5 btemrdiate minimum value of
N 1 063
t
C
pulsating test force
2nd maximum value of pulsating
Fcmin

N - 1 570
test force F2anax
3v
- Final static test force
Flfin(=FlS,J 2 784 -
6 Fa" c= F2qJ - 2 747
Prescribed number of cycles 1 2x lo6
NOTE The specific values of the diierent test forces are basad on reference values, as described in 112.2.2.
v

Q IS0 2006 - All rights resenred

 Annex D
(informative)

Summary of the records to be entered in the test laboratorylfacility log

D.1 Log records required for equipment

0.1.1 Specific records of types of equipment

The specific types of equipment (end attachments, jigs, measuring devices, test equipment) used, together
with a statement of essential features of the system, if appropriate, in accordance with 13.1 to 13.4.

0.1.2 Specific records of proof test of end attachments

a) The details of the assembly of end attachments, in accordance with 13.2.2.2.1;

b) the details of the adjustment of the top and bottom load application points PT and PB, in accordance with
13.2.2.2.2;

c) the orientation a) or b) in which the assembly is mounted in the test equipment and the test loading level
to be applied, together with the corresponding values of test forces F or FR, in accordance with
13.2.2.2.3;

d) the values of the displacements 4 and 62 of the moving load application point from its reference position
in the test equipment, in accordance with 13.2.2.2.5and 13.2.2.2.6;

e) the application of a specific value of proof test force FW or FRpa,

determined in accordance with the
OPTION described in 13.2.2.1, in accordance with 13.2.2.2.6;

9 the value of the displacement 6 of the moving load application point from its reference position in the test
equipment, in accordance with 13.2.2.2.7;

g) the values of the deflection Dl and the permanent deformation D2,in accordance with 13.2.2.2.8;
h) the results in accordance with 13.2.2.2.10.

D.1.3 Specific records of accuracy

a) Details of the methods used to measure accuracy and the calibration of the test equipment and any jig
and measuring device in accordance with 14.1;

b) the accuracy of equipment, i.e. the accuracy to which the test equipment and any jig and measuring
device measures linear and angular dimensions, test forces and the frequency of cyclic tests, in
accordance with 14.2;

c) the accuracy of procedure, i.e. the tolerances with which linear and angular dimensions are set and finally
adjusted, test forces and tilting angles are applied and the frequency of cyclic tests is controlled, in
accordance with 14.3.
 D.2 Log records required for test samples
a) a fully traceable identificationfor each sample tested and the date of submission - applied on submission.
If the sample has no permanent identification mark, the test laboratorytfacility shall affix one after the
testltests haslhave been completed;

b) a certificate of sampling from the normal production line, if appropriate, in accordance with 10.1.I;

c) the type of sample in accordance with 10.2.1 or 10.2.2. In special cases refer to the test submission
document;

d) the size of foot selected providing the worst-case loading in accordance with 10.1.2;

e) the type and identification of that part of the remainder of the test sample, to which the ankle-foot device
or foot unit is connected in accordance with 10.3.4;

f) the worst-case alignment position in accordance with 10.6, specified in the test submission document;

i g) the combination of segment lengths selected for the end attachments to achieve the fixed total length,
specified in Table 7, in accordance with 10.3.3;

h) the load application adaptor or lever used in accordance with 11.4; if this is attached by the
manufacturerlsubmitter, a fully documented test certificate shall be supplied by the
manufacturerlsubmitter;

i) the alignment in accordance with 10.5 and 11.7;

j) the test loading condition andlor loading level with which compliance or noncompliance shall be
demonstrated in accordance with 16.2.1.2, 16.3.1.2 andlor 16.4.1.3.

0.3 Log records required for tests

D.3.1 General records of all tests

a) The particular tests carried out in accordance with the relevant clauses of this lnternational Standard; in
special cases reference to the test submission document will be necessary;
4 b) the particular dimensions set and loads applied during the tests in accordance with the relevant clauses
of this International Standard; in special cases reference to the test submission document will be
necessary;

c) the date(s) at which the test(s) hasl(have) been carried out;

d) the test results, i.e. the statement that the ankle-foot device or foot unit submitted for test complies with
the requirements of this lnternational Standard, or the reason why it does not comply with these
requirements.

0.3.2 Specific records of static proof tests

0.3.2.1 For each test sample of the ankle-foot device or foot unit submitted for test, taken from the
prescribed batch according to 16.2.3, records of

a) the application of the static proof test as part of the alternative static ultimate strength test of Annex B in
accordance with 16.2.1 .I,Clause B.l and 8.2 c) [see also D.4.1 b)];

b) the realignment and re-use of a test sample that has completed the cyclic test procedure (including the
final static test) without failing, in accordance with 16.2.1.2;

8 IS0 2006 -All rights resewed 75

c) the test loading level to be applied, together with the corresponding values of tilting angles of the foot
platform and test forces, making specific reference to the application of the additional test loading level
P6, specified in Annex C, if appropriate, in accordance with 16.2.1.2;

d) the use of a special jig in accordance with 16.2.1.2;

e) the individual settings for the preparation of the test equipment and the arrangement of the foot platform
for heel loading, including the positioning of the specific heel block, in accordance with 16.2.1.3;

f) the finding whether or not the test sample sustains heel loading by the proof test force F,, and, if it does
not, the highest value of test force reached or the time for which the prescribed value of the proof test
force Flsphas been maintained in accordance with 16.2.1.5;

g) the decision on the application of the test procedure in forefoot loading in accordance with 12.3.3
and 16.2.1.5;

h) upon inspection of the test sample, the nature and, if possible, the location of any damage in accordance
with 16.2.1.6;

i) the individual settings for the arrangement of the foot platform for forefoot loading, including the
positioning of the specific heel block, in accordance with 16.2.1.7;

j) the finding whether or not the test sample sustains forefoot loading by the proof test force F2= and, if it
does not, the highest value of test force reached or the time for which the prescribed value otthe pmof
test force F2sphas been maintained in accordance with 16.2.1.8;

k) .upon inspection of the test sample, the nature and, if possible, the location of any damage in accordance
with 16.2.1.9;

I) the decision on whether or not the test sample has passed the test procedure in heel loading and the test
procedure in forefoot loading in accordance with 16.2.1.lo;

m) the repetition of the test on a substitute test sample if a test sample, which has already passed the cyclic
test for ankle-foot devices and foot units, fails to satisfy the performance requirement of 16.2.2 in heel
loading or in forefoot loading, including all specific records called for [a) to I)], in accordance
with 16.2.1.11.

D.3.2.2 For the ankle-foot device or foot unit submitted for test records of the decision on the compliance
with the static proof test for ankle-foot devices and foot units of this International Standard in accordance with
16.2.3, resulting in

a) a statement of compliance or

b) a record of the reason or reasons why compliance cannot be claimed.

D.3.3 Specific records of static ultimate strength tests

D.3.3.1 For each test sample of the ankle-foot device or foot unit submitted for test, taken from the
prescribed batch according to 16.3.3, records of

a) the application of the alternative static ultimate strength test of Annex B in accordance with 16.3.1.1,
16.3.1.5 and 16.3.1.11 [see f) and p)] [and also 16.3.1.17 as an option - see x)]. [For details of the
application see D.4.1 a)];

b) the realignment and re-use of a test sample that has completed the static proof test andlor the cyclic test
procedure (including the final static test) without failing, in accordance with 16.3.1.2;

Q IS0 2006 -All rights resenred

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u) the decision on whether or not the test sample referred to in 16.3.1.2 has passed the test procedure in
heel loading (16.3.1.2 to 16.3.1.5) and the test sample referred to in 16.3.1.8 has passed the test
procedure in forefoot loading (16.3.1.8 to 16.3.1.I
1) in accordance with 16.3.1.14;

v) the repetition of the test on a substitute test sample in the failed direction of loading if a test sample that
has already passed the static proof test andlor the cyclic test, fails to satisfy either of the performance
requirements of 16.3.2 in heel loading or in forefoot loading, including all specific records called for [a) to
u)], in accordance with 16.3.1.15;

w) the repetition of the test on a substitute test sample in the failed direction of loading if a test sample that
has already passed the static ultimate strength test in one direction of loading, fails this test in the other
direction of loading, including all specific records called for [a) to u)], in accordance with 16.3.1.16;

x) (as an option) the repetition of the test on a substitute test sample in the failed direction of loading at an
increased rate of loading [see a)] if a test sample fails this test in one direction of loading at a rate of
loading of between 100 Nls and 250 Nls, including all specific records called for [a) to u)], in accordance
with 16.3.1.17.

D.3.3.2 For the ankle-foot device or foot unit submitted for test records of the decision on the compliance
with the static ultimate strength test for ankle-foot devices and foot units of this International Standard in
accordance with 16.3.3, resulting in

a) a statement of compliance or

b) a record of the reason or reasons why compliance cannot be claimed.

D.3.4 Specific records of cyclic tests

D.3.4.1 For each test sample of the ankle-foot device or foot unit submitted for test, taken from the
prescribed batch according to 16.4.3, records of

a) the test loading level to be applied, together with the corresponding profiles of the tilting angle At) of the
oscillating foot platform and the pulsating test force F,(t) or Fc(y), making specific reference to the
a p p l i o n of the additional test loading level P6 specified in Annex C, if appropriate, in accordance
with 16.4.1.3;

b) the use of a special jig in accordance with 16.4.1.3;

c) the individual settings for the preparation of the test equipment and the arrangement of the foot platform,
including the positioning of the specific heel block, in accordance with 16.4.1.4;

d) the individual settings of the means of resistance to dislocation of the test sample during its lift-off phase
in accordance with 16.4.1.5;

e) the finding whether or not the test sample sustains heel loading by the maximum test force F,,, and
forefoot loading by the maximum test force , , ,F and, if it does not, the highest value of test force
reached in each direction of loading in accordance wth 16.4.1.6;

9 the decision on the termination of the test in accordance with 16.4.1.6;

g) the frequency called for in accordance with 12.3.5 a), together with the number of cycles required to settle
down, in accordance with 16.4.1.7;

h) a statement whether the profiles of the test force Fc(t) or Fc(d and the tilting angle At) of the oscillating
foot platform are applied in accordance with 13.4.2.10, 14.3 f), g) and h), in accordance with 16.4.1.7;

i) the agreement on a frequency differing from the prescribed value in accordance with 16.4.1.7;

Q IS0 2006 -All rights reserved

I
3
j) the termination of the test, if the pulsating test force Fc(t) or Fc(fi andlor the tilting angle At) of the
oscillating foot platform cannot be applied at any frequency agreed upon between the test
laboratorytfacilityand the manufacturerlsubmitter, in accordance with 16.4.1.7;

k) the frequency applied, i.e. the frequency called for or agreed upon [see g) and i)], together with the results
of the inspecbon of the waveform and the decision on the continuation of the test in accordance
with 16.4.1.8;

I) the details of the exchangelreplacement of specified parts, including the number of cycles at shutdown
and the conditions of the restart of the test in accordance with 12.3.5 b), 16.4.1.2 a) and 16.3.1.9;

m) the number of cycles at shutdown and whether failure has occurred, in accordance with 16.4.1.10;

n) the finding whether or not the test sample that has passed the cyclic test sustains the final static loading
successively applied by the test force FIfinto the heel and by the test force Fan to the forefoot and, if it
does not, the highest value of test force reached in each direction of loading or the time for which the
prescribed values of the final static test forces FiCnand F2finhave beenmaintained in accordance
with 16.4.1.11;
v
0) the decision on whether the test sample has passed or failed the cyclic test procedure in accordance
with 16.4.1.12;

p) upon inspection of the test sample, the nature and, if possible, the location of any damage in accordance
with 16.4.1.13;

q) upon visual examination of the test sample at the request of the manufacturerlsubmitter, the presence,
location and nature of any fractures andlor cracks, together with the magnification used, in accordance
with 12.3.4 c), 16.4.1.2 c) and 16.4.1.14.

D.3.4.2 For the ankle-fwt device or foot unit submitted for test records of the decision on the compliance
with the cyclic test for ankle-foot devices and foot units of this International Standard in accordance with
16.4.3.1, resulting in

a) a statement of compliance or

b) a record of the reason or reasons why compliance cannot be claimed.

b 0.4 Log records required for the alternative static ultimate strength tests according
to Annex B
D.4.1 For each test sample of the ankle-foot device or foot unit submitted for test, taken from the
prescribed batch according to 16.3.3, records of

a) the rate of loading and the highest value of test force and whether failure has occurred in accordance with
8.2 b) [see also D.3.3.1 a)];

b) the results of the subsequent static proof test in accordance with 8.2 c) [see also 0.3.2.1 a)].

D.4.2 For the ankbfoot device or foot unit submitted for test records of the decision on the compliance
with the alternative static ultimate strength test for ankle-foot devices and foot units of this International
Standard in accordance with 8.2 d), resulting in

a) a statement of compliance or

b) a record of the reason or reasons why compliance cannot be claimed.

-
Q IS0 2006 All rights regenred
 Annex E
(informative)

Information on Technical Report lSO/TR 22676 111

€.I
Background statement
The guidance offered in ISOlTR 22676 has required extensive analytical work which would have enlarged this
International Standard without directly supporting its application.

Most of the results from this work support, however, the understanding of the theoretical and technical
background and provide valuable findings concerning the design of appropriate test equipment.

The guidance offered can also serve as a basis for deliberations and decisions on a uniform design concept
for the test equipment required, in order to optimize the conditions of comparability of test results achieved at 0
different places.

ISOKR 22676 is, therefore, considered to be an appropriate means to make this information accessible to all
interested parties.

E.2 Contents of lSO/TR 22676

For ease in handling, Table E.l lists the contents of ISOITR 22676:2006 and also indicates, which of the items
covered are also dealt with in this InternationalStandard.

Q IS0 2008 - All rights resenred

 Table E.l -Contents of ISOrrR 22676 and list of corresponding clauseslsubclauses of this
International Standard, in which selected items are dealt with
Comsponding
Clauses and subclauses of ISORR 22676:2006 clausadsubclauses
of this standard
No. Heading Page No. Page
2 Guidance on the specificationof the test loading conditions of IS0 22675 1 A.2 63
2.1* General 1 A.2.1 63
2.2 Directions of static and maximum cyclic heel and forefoot reference loading 1 A.2.2 64
2.2.1" Basic relationships and conditions 1 A.2.2.1 64
2.2.2* Lines of action of the resultant reference forces FR1and FR2 2 A.2.2.2 64
2.2.3' Position of the top load application point PT 3 A.2.2.3 65
2.3" Magnitudes of static and maximum cyclic heel and forefoot reference loading 6 A.2.3 66
2.4 Reference test loading conditions of static and cyclic tests 7 A.2.4 67
2.4.1" Static tests 7 A.2.4.1 67
2.4.2** Cyclic test 8 A.2.4.2 67
3 Guidance on the design of appropriate test equipment for the application of 20 - -
IS0 22675
3.1 Background statement 20 - -
3.2 Basic design for test equipment 20 - -
3.3 Design variants for load application 24 - -
3.3.1 General 24 - -
3.3.2 Design variant A 24 - -
3.3.3 Design variant B 24 - -
3.3.4 Main differences between design variants A and B 25 - -
3.4 Examples of crank gear designs 25 - -
3.4.1 General 25 - -
3.4.2 Asymmetrical ( 6 0 )crank gear 25 - -
3.4.3 Symmetrical (50:50) crank gear 26 - -
3.5 Effect of deviations of the tilting angle 1(t) from the specified profile (curve), 30 - -
addressed in 3.4, on the test loading conditions of IS0 22675
3.6 Effect of the position of the tilting axis TA of the foot platform on the elevation E 35 E.3.2 82
and A-P displacement 4 0 f the test sample at the foot
3.6.1* General 35 E.3.2.1 82
3.6.2 Position of the tilting axis TA of the foot platform 36 - -
3.6.3 Values of elevation E 36 - -
3.6.4 Values of A-P displacement 4 37 - -
3.6.5" Condusions 39 E.3.2.2 82
3.7. Effect of the elevation E and A-P displacement u o f the test sample, caused by 43 E.3.3 83
the tilting of the foot platform, on the test loading conditions of IS0 22675
3.8 Transposition of the top load application point PTfor compensation of the 49 E.3.4 86
dependence of the position of the tilting axis TA of the foot platform on the foot
length L
3.8.1" General 49 E.3.4.1 86
3.8.2." Possibilities of transposing the top load a p p l i i i n point PT 49 E.3.4.2 86
3.8.3" Practicality 50 E.3.4.3 87
3.9 Effed of the position of the tilting axis TA of the foot platform on the tilting 53 - -
moment and the driving toque
3.10 Alternative design of foot platform 58 - -
NOTE m.of wb&ums marked ara fully indudedin Annexes A and E; #ems of subclauses marked 'are only covsred in part.

-
Q IS0 2006 All rights reserved 81
E.3 Selected items of lSO/TR 22676

E.3.1 General
In addition to the information on lSO/TR 22676 given in E.2, selected items of the technical report directly
related to specific normative elements of the main body of this International Standard are addressed in A.2
and E.3.

E.3.2 Effect of the position of the tilting axis TA of the foot platform on the elevation E and
the A-P displacement 4 o f the test sample at the foot

E.3.2.1 General

The tilting of the foot platform during the cyclic test up to the values occurring at the instant of heel contact
(M= - 20") and at the instant of toe-off (fro = 40°), specified in Table 11, can move the ankle-foot device or
foot unit by considerable amounts of both elevation E, illustrated in Figure E.1, and A-P displacement ;A
illustrated in Figure E.2.

This is not desirable, particularly because any A-P displacement 4 o f a test sample at the foot will result in an
angular movement Ap of the test sample about the top load application point PT, as addressed in E.3.3. The
higher the maximum value of A-P displacement ;A the greater the angular movement Ap and hence, the
greater the deviations from the specified test loading conditions will be.

As a general rule, the maximum value of angular movement A p about the top load application point PT at the
instants of F,,, (1st maximum of the loading profile) and F2,ax (2nd maximum of the loading profile)
should not exceed 1O.

As is demonstrated in 4.6 of lSO/TR 22676:2006, this can be achieved by an appropriate positioning of the
Wing axis TA of the foot platform.

E.3.2.2 Conclusions

The analysis in 4.6 of lSO/TR 22676:2006 indicates the position of the tilting axis TA, which minimizes the
values of the elevation E and the AIP displacement AJ at

fTA, = 0,365 L and UTA, = 0,l L

where L is the foot length in centimetres.

The coordinates dearly indicate a dependence of the position of the titting axis TA on the foot length L.

The coordinatesfTA, and UTA, are specified in Table 7 for a wide range of foot lengths, L. In addiin,
Table 7 includes the above equations that determine these coordinates for any other foot length.

NOTE The position of the tilting axis TA specified above is also illustrated in Figure E.5.

In order to limit the complexity of the design of the foot platform, it is possible to regard the dependence of the
positii of its tilting axis TA on the foot length, L by a corresponding transposition of the related top load
application point PT, which needs to be adjusted anyway, since it i s also dependent on the foot length L.

This can be cartied out in several ways, described in E.3.4.

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E.3.4 Transposition of the top load application point PT for compensation of the
dependence of the position of the tilting axis TA of the foot platform on the foot
length L

E.3.4.1 General

As already indicated in E.3.2.2, it is possible to take account of the dependence of the position of the tilting
axis TA of the foot platform on the foot length L by a corresponding transposition of the related top load
application point PT, which needs to be adjusted anyway, since it is also dependent on the foot length L.

This procedure has two advantages:

- It simplifies the setting-up of the test sample in the test equipment, since it reduces the amount of
adjustment work and

- it does not necessarily require a design of the foot platform that allows the position of its tilting axis TA to
be adjusted (but see NOTES to E.3.4.2).

E.3.4.2 Possibilities of transposing the top load application point PT

According to Figure E.4, the procedure addressed in E.3.4.1 can be canied out in principle by

a) specifying a fixed standard or compromise position of the tilting axis TA of the foot platform, determined
by the offsetsfTA, 2. and UTA, 32 (see NOTE 1) or UTA, C,respectively (see NOTE 2),

b) transposing the top load application point PT relevant to a specific foot length L of the test sample
parallel to thefaxis by qTA,L, the value of 4iA = fiA, 20 -fTA, L) representing the difference between
the offsetfTA, 2o of the fixed position of the tilting'axis TA [see a)] and its offsetfTA, relevant to a specific
foot length L (see Table E.2),

c) transposing the top load application point PT, relevant to a specific foot length L of the test sample
parallel to the raxis by AuTA, [see I)] or A*& [see 2)], where

1) the value of hTA, = ( q 32 - qA represents the difference between the offset UTA 32 of the fixed
position of the tihng ax is+^
[see a)] and its offset UTA, relevant to a specific foot lengh L, and

2) the value of AuTA =

,,,q( 32 - UTA, C) represents the difference between the offset UTA 32 of the
fixed position of the tilting axls TA [see a)] and a specified compromise offset qA,of the tilting axis
TA of the foot platform, uniformly applied to test samples of any foot length L,

the values of AuTA, and AuTA, corresponding to the thickness of the compensation plates used for the
elevation of the contact surface of the foot platform required to adapt it to the value of UTA, or w,C,
respectively (but see NOTE 3).

The results of c) 1) and c) 2) are also listed in Table E.2.

NOTE 1 The possibilities of transposing the top load application point PT shown in E.3.4.2, Figure E.4 and Table E.2
rsquire the fixed standard position of the tilting axis TA to be determined by a value relevant to the smallest size
and a value of uTA, relevant to the largest size of foot covered by the range of foot lengths 20 an s L s 32 an,w h i is
considered to cover the vast majority of sizes expected to be submited for test. If appropriate, this range can easily be
+,,,
extended to smaller or larger sizes with subsquent changes of the values of w T A , L, and h A , c.
NOTE 2 As is demonstrated in 3.8 of ISOlTR 22676:2006, the most appropriate uniform compromise offset %A, of
the tilting axis TA of the foot platform addressed in c) 2) is UTA, = 26 mm (0,l L according to E.3.2.2 for a foot of the
length L = 26 an) applicable to all foot lengths L, applied together with the individual offset ffA = 0,365 L according to
E.3.2.2 relevant to each individual foot length L (see Figure E.5). The resulting displacements 4 w i l l cause angular
movements Aq, about the top load application point PT in an arrangement according to 13.4.2 and Figure 5 keeping just
below lo (0,9g0).

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 NOTE 3 A compromise in the design of the foot platform may be the limited adjustability of the position of its tilting
axis TA only in the udiredion. Its technical realization is considered to be rather simple, since the fixed distance between
two successive u-positions of the tilting axis TA, the value of which is 1 mm (see Figure E.5 and Table E.2). m n be
provided, for example, by a grid of keyways cut into the contact surfaces of the adjustable bearing Mocks of the tilting
axis TA and the foot platform, to which these am attached by screws. In this case the compensation plates addressed in c)
are, of course, not needed.

E.3.4.3 Practicality

The procedure described in E.3.4.1 and E.3.4.2 is considered to be both appropriate and practicable.

- It provides appropriate means of diminishing the elevation E and A-P displacement Af of the test sample
at the foot, caused by the tilting of the foot platform up to the values occurring at the instants of heel
contact and toe-off (see E.3.2).

- It simplifies the setting-up of the test sample in the test equipment, since it reduces the amount of
adjustment work (see E.3.4.1).

0 - It does not increase the complexrty of the design of the foot platform to an intolerable extent (see E.3.4.2).

The only dierence to be regarded is, that the u-axis of the coordinate system (see 6.2 and Figure 1) and the
effective ankle-joint centre (see 6.7.3) located on it, which are used as reference for the alignment of the test
sample and its setting-up in the test equipment, no longer have a fixed position relative to the base frame of
the test equipment. Moreover, they keep their fixed position relative to the top load application point PT and,
hence, are transposed together with it.

G IS0 2006 -All rights resenred

Key
1 individual position of top load application point P T , for different foot lengths L
2 transposed positions of top load application point PT for different foot lengths L; positions marked square transposed
,
by g T A , and hTA. , and positions marked rhombi'transposed by W T A , ,and &qA,
3 individual position of tilting axis TA, of foot platform for different foot.lengths L
4 fixed standard or compmmise position of tilting axis TA of foot platform at&, , and UTA, 32 or UTA, C , respectively
5 individual elevation of contact surface of foot platform by compensation plates of diirent thickness h A , (or by
corresponding adjustment) for adaptation to individualfoot length L
,
6 uniform elevation of contact surface of foot platform by h T A , for adaptation to compromise offset UTA, applicable to
all foot lengths L

-
Flgure E.4 Illustration of porrslbllitiesof transposing the top load application point PT
for compensation of the dependence of the position of the tilting axis TA of the foot platform
on the foot length L
f; u axes of coordinate system
C,. 20, %, 32 specific positions of effective anklejoint centre CA related to feet of specific lengths L = 20 an, L = 26 an
andL=32an
T specific positions of tilting axis TA of foot platform related to feet of specific lengths L = 20 an, L = 26 an
andL132cm
*A, C, 20, 26.32 dimension of uniform compromise offset UTA, = UTA 28 = 26 mm (0,l x foot length L = 26 cm)nlated to
feetofspecificlengths~=20an.~=26anand~=~2cm
pel position of bottom load application point on heel
pen position of bottom load mication point on forefoot
4fez 2o anterior displacement of bottom load application point Pm at the instant of maximum forefoot reference
loading (test force F= F-) relatedto foot of specific length, L = 20 an
%o, 32 posterior displacement of point of foot at instant of toe-off (test force F = 0) related to foot of specific
length, L = 32 an
L foot length

-
Figure E.5 Illustration of the e a t of a fixed compromise offset uTA, of the tilting axis TA
of the foot platfonn on the A-P displacement Af at the foot [see E.3.4.2c) 2)]
Table E.2 -
Possibilities of transposing the top load application point PT for compensationof the
dependence of the position of the tilting axis TA of the foot platform on the foot length L
Coordinates of Coordinates of Procedure according to Transposition of PT
'mgulaf' U ~ ~ l position
a f ' E.3.4.2 b) and E.3.4.2 c) 1) according to E.3.4.2 b)'and
position of top of tilting axis TA of for compensation of fixed E.3.4.2 c) 2) for compensation
load application foot platform position of tilting axis TA of fixed compromise position
point of foot platform at of tilting axis TA of foot
Foot p ~ L, JTA, 20 = 73 and UTA,32 = 32 platform at
fTA, = 73 and UTA, c = 26
La
Transposition Use of
cm of compen-
JT. L UT. L &A.L U ~L ~ ,
PT, L sation plates Afi~
L . AUTA. c
of thickness

MTA.
L A ~ T AL.
mm mm mm mm mm mm mm mm mm
20 17 445 73 20 0 12 12 0 6
21 18 467 77 21 -4 11 11 -4 6
22 19 489 80 22 -7 10 10 -7 6
23 19 511 84 23 - 11 9 9 - 11 6
24 20 534 88 24 - 15 8 8 - 15 6

The possiMIibles of transposing the top load application point PTshown require the fixed standard position of the Whng axis TA to
be determined by a value of fTk ralevent to the smallest sue and a value of vk relevant to the largest size of foot cowred by
therangeoffootlengths20~L~32.
For a real arrangement of foot platform with the tilting axis TA located at a uniform compromise offset ur4 above the platform

Q IS0 2006 -All rights resenred

 Annex F
(informative)

Reference to the essential principles of safety and performance of

medical devices according to ISOITR 16142

This International Standard has been prepared to support the essential principles of safety and performance
of prosthetic ankle-foot devices and foot units as medical devices according to ISOTTR 16142. This
InternationalStandard is suitable for conformity assessment purposes.

Compliance with this lnternational Standard provides one means of demonstrating conformity with specific
essential principles of lSO/TR 16142. Other means are possible.

NOTE 1 The essential principles of safety and performance according to ISOITR 16142 conform, in both strudure
and contents, to the essential requirements according to Annex I of the European Directive 931421EEC concerning
medical devices with a few exceptions.

NOTE 2 This annex has been endosed to provide the same information as original Annex ZA, which has been
removed from this International Standard for formal reasons. Table F.l c o n f m s to Table ZA.1 of original Annex ZA in
both structure and contents, with the exception of the column headings.

Table F.1 -Correspondence between this International Standard and

the essential principles of lSO/TR 16142

Clauseslsubclawes Corresponding essential principle Qualifying

of this International Standard of lSO/TR 16142:1999 remarkslnotes
5; 6; 7; 8; 9; 10; 15; 16 A.2, A.4, A.12.7.1
5, 19,20 A.9.1
5; 19; 20 A.13
20 A.13

@ IS0 2006 -All rights reserved

 Bibliography

[I] ISOKR 22676:2006, Prosthetics - Testing of ankle-foot devices and foot unzs - Guidance on the
application of the test loading conditions of EN IS0 22675 and on the design of appropriate test
equipment

[2] ISOKR 16142:1999, Medical devices- Guidance on the selection of standards in support of
recognized essential principles of safety and performance of medical devices