Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods (ISO 10328:2006)
DIN EN ISO 10328:2007-04 (E)
Prosthetics – Structural testing of lower-limb prostheses – Requirements and test
methods (ISO 10328:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….8
Introduction ……………………………………………………………………………………………………………………………………9
1 Scope ……………………………………………………………………………………………………………………………10
2 Normative references ……………………………………………………………………………………………………11
3 Terms and definitions ……………………………………………………………………………………………………11
4 Designations and symbols of test forces and moments …………………………………………………12
5 Strength and related performance requirements and conditions of use ………………………….12
6 Coordinate systems and test configurations ………………………………………………………………….14
6.1 General …………………………………………………………………………………………………………………………14
6.2 Axes of coordinate systems ………………………………………………………………………………………….14
6.3 Reference planes …………………………………………………………………………………………………………..14
6.3.1 General …………………………………………………………………………………………………………………………14
6.3.2 Top reference plane, T …………………………………………………………………………………………………..14
6.3.3 Knee reference plane, K ………………………………………………………………………………………………..14
6.3.4 Ankle reference plane, A ……………………………………………………………………………………………….14
6.3.5 Bottom reference plane, B …………………………………………………………………………………………….15
6.4 Reference points …………………………………………………………………………………………………………..17
6.5 Test force ……………………………………………………………………………………………………………………..17
6.6 Load line ……………………………………………………………………………………………………………………….17
6.7 Longitudinal axis of the foot and effective joint centres and centrelines …………………………17
6.7.1 General …………………………………………………………………………………………………………………………17
6.7.2 Longitudinal axis of the foot ………………………………………………………………………………………….17
6.7.3 Effective ankle-joint centre ……………………………………………………………………………………………17
6.7.4 Effective ankle-joint centreline ………………………………………………………………………………………19
6.7.5 Effective knee-joint centreline ……………………………………………………………………………………….19
6.7.6 Effective knee-joint centre …………………………………………………………………………………………….20
6.8 Reference distances ……………………………………………………………………………………………………..20
6.8.1 Offsets ………………………………………………………………………………………………………………………….20
6.8.2 Combined offsets ………………………………………………………………………………………………………….20
6.8.3 Effective lever arms LA and LK ……………………………………………………………………………………..20
6.8.4 Distance LBT ………………………………………………………………………………………………………………..20
7 Test loading conditions and test loading levels ……………………………………………………………..20
7.1 Test loading conditions …………………………………………………………………………………………………20
7.1.1 General …………………………………………………………………………………………………………………………20
7.1.2 Test loading conditions of principal structural tests ………………………………………………………21
7.1.3 Test loading conditions of separate structural tests ………………………………………………………21
7.2 Test loading levels ………………………………………………………………………………………………………..21
8 Values of test loads, dimensions and cycles ………………………………………………………………….22
9 Compliance …………………………………………………………………………………………………………………..30
9.1 General …………………………………………………………………………………………………………………………30
9.2 Selection of tests required to claim compliance with this International Standard ……………30
9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices
or foot units, required to claim compliance with this International Standard …………………. 30
9.3.1 General ……………………………………………………………………………………………………………………….. 30
9.3.2 Particular arrangements concerning the ankle-foot device or foot unit …………………………. 30
9.3.3 Particular arrangements and requirements concerning the part required to connect the
ankle-foot device or foot unit to the remainder of the prosthetic structure …………………….. 30
9.4 Number of tests and test samples required to claim compliance with this International
Standard ……………………………………………………………………………………………………………………… 31
9.5 Multiple use of test samples …………………………………………………………………………………………. 31
9.5.1 General ……………………………………………………………………………………………………………………….. 31
9.5.2 Restriction …………………………………………………………………………………………………………………… 32
9.6 Testing at particular test loading levels not specified in this International Standard ……… 32
10 Test samples ……………………………………………………………………………………………………………….. 34
10.1 Selection of test samples …………………………………………………………………………………………….. 34
10.1.1 General ……………………………………………………………………………………………………………………….. 34
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot ……………………… 34
10.2 Types of test samples ………………………………………………………………………………………………….. 35
10.2.1 Complete structure ………………………………………………………………………………………………………. 35
10.2.2 Partial structure …………………………………………………………………………………………………………… 37
10.2.3 Any other structure ……………………………………………………………………………………………………… 37
10.3 Preparation of test samples …………………………………………………………………………………………. 37
10.4 Identification of test samples ……………………………………………………………………………………….. 38
10.5 Alignment of test samples ……………………………………………………………………………………………. 39
10.5.1 Test samples for principal tests and separate tests on knee locks ………………………………… 39
10.5.2 Test samples for separate tests on ankle-foot devices and foot units ……………………………. 39
10.5.3 Test samples for separate static ultimate strength tests in maximum knee flexion for
knee joints and associated parts ………………………………………………………………………………….. 40
10.5.4 Test samples for separate tests on knee locks ……………………………………………………………… 40
10.6 Worst-case alignment position of test samples …………………………………………………………….. 41
11 Responsibility for test preparation ……………………………………………………………………………….. 41
12 Test submission document ………………………………………………………………………………………….. 42
12.1 General requirements ………………………………………………………………………………………………….. 42
12.2 Information required for test samples …………………………………………………………………………… 43
12.2.1 All test samples …………………………………………………………………………………………………………… 43
12.2.2 Test samples for tests on ankle-foot devices and foot units ………………………………………….. 43
12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints
and associated parts ……………………………………………………………………………………………………. 43
12.3 Information required for tests ………………………………………………………………………………………. 44
12.3.1 General ……………………………………………………………………………………………………………………….. 44
12.3.2 For all tests ………………………………………………………………………………………………………………….. 44
12.3.3 For static tests in torsion and on ankle-foot devices and foot units ………………………………. 44
12.3.4 For static ultimate strength tests ………………………………………………………………………………….. 44
12.3.5 For cyclic tests …………………………………………………………………………………………………………….. 44
12.3.6 For tests in torsion ………………………………………………………………………………………………………. 44
12.3.7 For tests on ankle-foot devices and foot units ………………………………………………………………. 45
13 Equipment …………………………………………………………………………………………………………………… 45
13.1 General ……………………………………………………………………………………………………………………….. 45
13.2 Equipment for the principal tests specified in 16.2 and 16.3 ………………………………………….. 45
13.2.1 End attachments ………………………………………………………………………………………………………….. 45
13.2.2 Jig (optional) ……………………………………………………………………………………………………………….. 47
13.2.3 Test equipment ……………………………………………………………………………………………………………. 47
13.3 Equipment for the separate static test in torsion specified in 17.1 …………………………………. 49
13.3.1 Test equipment ……………………………………………………………………………………………………………. 49
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 … 49
13.4.1 Test equipment ……………………………………………………………………………………………………………. 49
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for
knee joints and associated parts specified in 17.3 ………………………………………………………… 53
13.5.1 Extension pieces …………………………………………………………………………………………………………. 53
13.5.2 Test equipment to perform static compression loading – (Compression testing machine
or other equipment) ………………………………………………………………………………………………………53
13.6 Equipment for the separate tests on knee locks specified in 17.4 …………………………………..53
13.6.1 End attachments …………………………………………………………………………………………………………..53
13.6.2 Jig (optional) …………………………………………………………………………………………………………………53
13.6.3 Test equipment ……………………………………………………………………………………………………………..53
14 Accuracy ………………………………………………………………………………………………………………………54
14.1 General …………………………………………………………………………………………………………………………54
14.2 Accuracy of equipment …………………………………………………………………………………………………54
14.3 Accuracy of procedure ………………………………………………………………………………………………….54
15 Test principles ………………………………………………………………………………………………………………55
15.1 General …………………………………………………………………………………………………………………………55
15.2 Static test procedure ……………………………………………………………………………………………………..55
15.3 Cyclic test procedure …………………………………………………………………………………………………….55
16 Test procedures – Principal structural tests ……………………………………………………………………55
16.1 Test loading requirements …………………………………………………………………………………………….55
16.1.1 Preparation for test loading …………………………………………………………………………………………..55
16.1.2 Application of test loading …………………………………………………………………………………………….55
16.2 Principal static test procedure ……………………………………………………………………………………….57
16.2.1 Principal static proof test ………………………………………………………………………………………………57
16.2.2 Principal static ultimate strength test …………………………………………………………………………….62
16.3 Principal cyclic test procedure ………………………………………………………………………………………66
16.3.1 General requirements ……………………………………………………………………………………………………66
16.3.2 Test method ………………………………………………………………………………………………………………….66
16.3.3 Performance requirements ……………………………………………………………………………………………70
16.3.4 Compliance conditions ………………………………………………………………………………………………….70
17 Test procedures – Separate structural tests ……………………………………………………………………74
17.1 Separate static test in torsion ………………………………………………………………………………………..74
17.1.1 General …………………………………………………………………………………………………………………………74
17.1.2 Purpose of test ……………………………………………………………………………………………………………..74
17.1.3 Test method ………………………………………………………………………………………………………………….74
17.1.4 Performance requirements ……………………………………………………………………………………………76
17.1.5 Compliance conditions ………………………………………………………………………………………………….76
17.2 Separate tests on ankle-foot devices and foot units ……………………………………………………….78
17.2.1 General …………………………………………………………………………………………………………………………78
17.2.2 Purpose of tests ……………………………………………………………………………………………………………78
17.2.3 Separate static proof test for ankle-foot devices and foot units ………………………………………78
17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units …………………….82
17.2.5 Separate cyclic test for ankle-foot devices and foot units ………………………………………………87
17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and
associated parts ……………………………………………………………………………………………………………92
17.3.1 General …………………………………………………………………………………………………………………………92
17.3.2 Purpose of test ……………………………………………………………………………………………………………..92
17.3.3 Applicability of the test to specific test samples …………………………………………………………….92
17.3.4 Test method ………………………………………………………………………………………………………………….93
17.3.5 Performance requirement ……………………………………………………………………………………………..93
17.3.6 Compliance conditions ………………………………………………………………………………………………….94
17.4 Separate tests on knee locks …………………………………………………………………………………………95
17.4.1 General …………………………………………………………………………………………………………………………95
17.4.2 Purpose of tests ……………………………………………………………………………………………………………95
17.4.3 Separate static proof test for knee locks ………………………………………………………………………..95
17.4.4 Separate static ultimate strength test for knee locks ………………………………………………………99
17.4.5 Separate cyclic test for knee locks ………………………………………………………………………………101
18 Test laboratory/facility log …………………………………………………………………………………………..110
18.1 General requirements ………………………………………………………………………………………………….110
18.2 Specific requirements ………………………………………………………………………………………………….110
19 Test report …………………………………………………………………………………………………………………. 110
19.1 General requirements ………………………………………………………………………………………………… 110
19.2 Specific requirements ………………………………………………………………………………………………… 111
19.3 Options ……………………………………………………………………………………………………………………… 111
20 Classification and designation ……………………………………………………………………………………. 111
20.1 General ……………………………………………………………………………………………………………………… 111
20.2 Examples of classification and designation ………………………………………………………………… 111
21 Labelling ……………………………………………………………………………………………………………………. 112
21.1 General ……………………………………………………………………………………………………………………… 112
21.2 Use of mark “*)” and warning symbol …………………………………………………………………………. 113
21.3 Examples of label layout …………………………………………………………………………………………….. 113
21.4 Label placement …………………………………………………………………………………………………………. 113
Annex A (informative) Description of internal loads and their effects ………………………………………….. 115
Annex B (informative) Reference data for the specification of test loading conditions and test
loading levels of principal cyclic tests ………………………………………………………………………… 119
Annex C (informative) Guidance on the application of an alternative static ultimate strength test .. 123
Annex D (informative) Guidance on the application of an additional test loading level P6 …………… 124
Annex E (informative) Summary of the records to be entered in the test laboratory/facility log …… 127
Annex F (informative) Background information on the loading profiles generated by test
equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot
units according to 17.2.5.1 …………………………………………………………………………………………. 142
Annex G (informative) Reference to the essential principles of safety and performance of medical
devices according to ISO/TR 16142 …………………………………………………………………………….. 144
Bibliography ……………………………………………………………………………………………………………………………… 145
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives ……………………………………………………………………………….. 146
Figure 1 — Coordinate systems for right and left-sided application ………………………………………………. 15
Figure 2 — Coordinate systems according to Figure 1 with reference planes ………………………………… 15
Figure 3 — Specific configuration with uB = 0, showing coordinate systems with reference planes
(see Figures 1 and 2), reference lines, reference points and test force, F, for right and
left- sided application …………………………………………………………………………………………………… 16
Figure 4 — Determination of longitudinal axis of foot (see 6.7.2), effective ankle-joint centre (see
6.7.3) and effective ankle-joint centreline (see 6.7.4) for test loading conditions I and II
and of combined bottom offset SB (see 6.8.2) for test loading condition II [see 7.1.2 b)] … 18
Figure 5 — Position of effective knee-joint centreline for prosthetic knee units of different types ….. 19
Figure 6 — Application of a specific test configuration with uB = 0 to a left-sided sample specified
in 10.2.1 ……………………………………………………………………………………………………………………….. 36
Figure 7 — Position of foot in test equipment (see 10.5.2, 13.4 and 17.2) ……………………………………….. 39
Figure 8 — Test configuration for the separate static ultimate strength test in maximum knee
flexion on knee joints and associated parts (see 10.5.3.1, 13.5 and 17.3.4) …………………….. 40
Figure 9 — Load cycle parameters for the principal cyclic test ……………………………………………………… 48
Figure 10 — Load cycle parameters for the separate cyclic test for ankle-foot devices and foot units
………………………………………………………………………………………………………………………………………52
Figure 11 — Illustration of test loading principle applied to a knee unit with attachments, aligned to
simulate a left-sided test sample (see 16.1.1) …………………………………………………………………56
Figure 12 — Method of calculating offsets at any height u = ux (see 16.1.1) …………………………………….57
Figure 13 — Flowchart for the principal static proof test, specified in 16.2.1.1 …………………………………61
Figure 14 — Flowchart for the principal static ultimate strength test, specified in 16.2.2.1 ………………65
Figure 15 — Flowchart for the principal cyclic test, specified in 16.3.2 Continued on Figures 16 and
17 ………………………………………………………………………………………………………………………………….71
Figure 16 — Flowchart for the principal cyclic test, specified in 16.3.2 Continued from Figure 15 and
continued on Figure 17 ………………………………………………………………………………………………….72
Figure 17 — Flowchart for the principal cyclic test, specified in 16.3.2 Continued from Figure 16 ……73
Figure 18 — Flowchart for the separate static test in torsion, specified in 17.1.3 ……………………………..77
Figure 19 — Flowchart for the separate static proof test for ankle-foot devices and foot units,
specified in 17.2.3.1 ……………………………………………………………………………………………………….81
Figure 20 — Flowchart for the separate static ultimate strength test for ankle-foot devices and foot
units, specified in 17.2.4.1 ……………………………………………………………………………………………..86
Figure 21 — Flowchart for the separate cyclic test for ankle-foot devices and foot units, specified in
17.2.5.1 Continued on Figure 22 …………………………………………………………………………………….90
Figure 22 — Flowchart for the separate cyclic test for ankle-foot devices and foot units, specified in
17.2.5.1 Continued from Figure 21 …………………………………………………………………………………91
Figure 23 — Flowchart for the separate static ultimate strength test in maximum knee flexion for
knee joints and associated parts, specified in 17.3.4 ………………………………………………………94
Figure 24 — Flowchart for the separate static proof test for knee locks, specified in 17.4.3.1 ………….98
Figure 25 — Flowchart for the separate static ultimate strength test for knee locks, specified in
17.4.4.1 ……………………………………………………………………………………………………………………….101
Figure 26 — Flowchart for the separate cyclic test for knee locks, specified in 17.4.5.1 Continued on
Figures 27 and 28 ………………………………………………………………………………………………………..107
Figure 27 — Flowchart for the separate cyclic test for knee locks, specified in 17.4.5.1 Continued
from Figure 26 and continued on Figure 28 ………………………………………………………………….108
Figure 28 — Flowchart for the separate cyclic test for knee locks, specified in 17.4.5.1 Continued
from Figure 27 …………………………………………………………………………………………………………….109
Figure 29 — General concept for the label layout ………………………………………………………………………….112
Figure 30 — Models for the label layout ………………………………………………………………………………………..114
Annex A (informative) Description of internal loads and their effects …………………………………………..115
Figure A.1 — Test loading condition I [see 7.1.2 a)] ………………………………………………………………………117
Figure A.2 — Test loading condition II [see 7.1.2 b)] ……………………………………………………………………..118
Table 1 — Designations and symbols of test forces and moments ………………………………………………….12
Table 2 — Categories of strength addressed in this International Standard, together with the related
performance requirements and test methods for their verification ………………………………… 13
Table 3 — Test loads and relevant references ……………………………………………………………………………….. 23
Table 4 — Test forces of the proof test of end attachments for test loading levels P5, P4 and P3
(see 13.2.1.2) ……………………………………………………………………………………………………………….. 24
Table 5 — Total length and segmental lengths of different types of test samples for principal tests
and separate tests on knee locks, for all test loading conditions and test loading levels
(see also 10.2, 10.3, 16.2, 16.3, 17.4 and Figure 2) …………………………………………………………. 24
Table 6 — Values of offsets for all principal tests (see 16.2 and 16.3) …………………………………………….. 25
Table 7 — Values of combined offsets related to the values of offsets listed in Table 6 (see 10.1.2
and 13.2.1.2.3) ……………………………………………………………………………………………………………… 25
Table 8 — Test forces of all principal tests and prescribed number of cycles of the cyclic test, for
test loading levels P5, P4 and P3 (see 16.2 and 16.3) …………………………………………………….. 26
Table 9 — Twisting moments of the separate static test in torsion (see 17.1) …………………………………. 27
Table 10 — Angles of directions of loading of all separate tests on ankle-foot devices and foot
units, for test loading levels P5, P4 and P3 (see 17.2 and Figure 7) ……………………………….. 27
Table 11 — Test forces of all separate tests on ankle-foot devices and foot units and prescribed
number of cycles of the cyclic test, for test loading levels P5, P4 and P3 (see 17.2) ………. 28
Table 12 — Loading parameters of the separate static ultimate strength test in maximum knee
flexion for knee joints and associated parts (see 17.3 and Figure 8) ……………………………… 28
Table 13 — Offsets of all separate tests on knee locks, for test loading levels P5, P4 and P3 (see
17.4) …………………………………………………………………………………………………………………………….. 29
Table 14 — Test forces of all separate tests on knee locks and prescribed number of cycles of the
cyclic test, for test loading levels P5, P4 and P3 (see 17.4) ……………………………………………. 29
Table 15 — Tests required to claim compliance with this International Standard for prosthetic
structures representing complete assemblies, partial assemblies or individual
components ………………………………………………………………………………………………………………… 32
Table 16 — Number of tests and test samples required to claim compliance with this International
Standard ……………………………………………………………………………………………………………………… 33
Table 17 — Option for end attachments of specific design ……………………………………………………………. 46
Table A.1 — Positive internal forces and moments with descriptions of their effects …………………… 116
Table B.1 — Values of ankle and knee moments related to test force F = Fcr for different test
loading conditions and test loading levels of principal cyclic tests ……………………………… 120
Table B.2 — Calculated values of axial force and twisting moment related to test force F = Fcr for
different test loading conditions and test loading levels of principal cyclic tests …………. 120
Table B.3 — Values of ankle and knee moments related to test force F = Fcmax for different test
loading conditions and test loading levels of principal cyclic tests ……………………………… 121
Table B.4 — Calculated values of axial force and twisting moment related to test force F = Fcmax
for different test loading conditions and test loading levels of principal cyclic tests ……. 121
Table D.1 — Test forces of the proof test of end attachments for test loading level P6 (see 13.2.1.2) 125
Table D.2 — Test forces of all principal tests and prescribed number of cycles of the cyclic test, for
test loading level P6 (see 16.2 and 16.3) ……………………………………………………………………….125
Table D.3 — Test forces of all separate tests on ankle-foot devices and foot units and prescribed
number of cycles of the cyclic test, for test loading level P6 (see 17.2) …………………………126
Table G.1 — Correspondence between this International Standard and the essential principles of
ISO/TR 16142 ………………………………………………………………………………………………………………144
Table ZA.1 — Correspondence between this European Standard and EU Directives ……………………..146