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

Non-active surgical implants – Implants for osteosynthesis – Particular requirements (ISO 14602:2010)

Abstract

ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.

In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

DIN EN ISO 14408:2009-08 (D)
Trachealtuben für die Laserchirurgie – Anforderungen an die Kennzeichnung und die
begleitenden Informationen (ISO 14408:2005); Deutsche Fassung EN ISO 14408:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………5
4 Kennzeichnung……………………………………………………………………………………………………………………..6
4.1 Verwendung von Symbolen …………………………………………………………………………………………………..6
4.2 Kennzeichnung……………………………………………………………………………………………………………………..6
4.3 Kennzeichnung der Verpackungen ………………………………………………………………………………………..7
4.4 Kennzeichnung der Sammelverpackungen…………………………………………………………………………….7
5 Vom Hersteller bereitzustellende Informationen …………………………………………………………………….8
5.1 Anweisungen für die Vorbereitung und Verwendung des laserresistenten Trachealtubus
und der behandelten Teile des Trachealtubus………………………………………………………………………..8
5.2 Indikationen für die Anwendung…………………………………………………………………………………………….8
5.3 Warnhinweise und Vorsichtsmaßnahmen für die Verwendung des Tubus………………………………8
5.4 Grafische Darstellung der Prüfergebnisse auf die Laserresistenz …………………………………………..8
Literaturhinweise…………………………………………………………………………………………………………………………….10
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG ……………………………………………….11

Non-active surgical implants – Joint replacement implants – Particular requirements (ISO 21534:2007)

Abstract

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term “implant”.

ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

DIN EN ISO 21534:2009-08 (D)
Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere
Anforderungen (ISO 21534:2007); Deutsche Fassung EN ISO 21534:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….4
Einleitung …………………………………………………………………………………………………………………………………………5
1 Anwendungsbereich ……………………………………………………………………………………………………………..6
2 Normative Verweisungen ………………………………………………………………………………………………………6
3 Begriffe …………………………………………………………………………………………………………………………………6
4 Beabsichtigte Funktion………………………………………………………………………………………………………….7
5 Konstruktionsmerkmale ………………………………………………………………………………………………………..8
5.1 Allgemeines ………………………………………………………………………………………………………………………….8
5.2 Oberflächenbeschaffenheit von Implantaten aus Metall oder Keramik bei Artikulation mit
ultrahochmolekularem Polyethylen (UHMWPE)………………………………………………………………………8
5.3 Oberflächenbeschaffenheit von Teilimplantaten aus Metall und Keramik………………………………..8
5.4 Oberflächen kugelkonvexer Implantate aus Metall oder Keramik bei Artikulation mit
UHMWPE ………………………………………………………………………………………………………………………………8
5.5 Oberflächen kugelförmiger Teilimplantate aus Metall und Keramik…………………………………………8
5.6 Oberflächen kugelkonkaver UHMWPE-Komponenten …………………………………………………………….9
6 Werkstoffe …………………………………………………………………………………………………………………………….9
6.1 Allgemeines ………………………………………………………………………………………………………………………….9
6.2 Verschiedenartige Metalle oder Legierungen …………………………………………………………………………9
7 Designprüfung ………………………………………………………………………………………………………………………9
7.1 Allgemeines ………………………………………………………………………………………………………………………….9
7.2 Präklinische Bewertung…………………………………………………………………………………………………………9
7.2.1 Allgemeines ………………………………………………………………………………………………………………………….9
7.2.2 Messung der Oberflächenrauheit …………………………………………………………………………………………10
7.2.3 Messung der Rundheit…………………………………………………………………………………………………………10
7.3 Klinische Prüfung………………………………………………………………………………………………………………..10
7.4 Überwachung nach Markteinführung……………………………………………………………………………………10
8 Herstellung und Kontrolle ……………………………………………………………………………………………………10
8.1 Allgemeines ………………………………………………………………………………………………………………………..10
8.2 Metallische Oberflächen ………………………………………………………………………………………………………10
8.3 Kunststoffoberflächen …………………………………………………………………………………………………………11
8.4 Keramikoberflächen …………………………………………………………………………………………………………….11
9 Sterilisation …………………………………………………………………………………………………………………………11
9.1 Allgemeines ………………………………………………………………………………………………………………………..11
9.2 Verfallsdatum………………………………………………………………………………………………………………………11
10 Verpackung …………………………………………………………………………………………………………………………11
11 Bereitstellung von Informationen durch den Hersteller…………………………………………………………11
11.1 Allgemeines ………………………………………………………………………………………………………………………..11
11.2 Beschriftung von nur an einer Körperseite anzuwendenden Implantaten………………………………12
11.3 Anweisungen zur Ausrichtung des Implantats ……………………………………………………………………..12
11.4 Kennzeichnung zur Ausrichtung des Implantats…………………………………………………………………..12
11.5 Kennzeichnungsstelle am Implantat …………………………………………………………………………………….12
11.6 Einschränkungen der Anwendung……………………………………………………………………………………….12
11.7 Resterilisation von Keramiken aus Zirkoniumdioxid …………………………………………………………….12
11.8 Beschriftung von Implantaten zur Anwendung mit oder ohne Knochenzement …………………….12

Anhang A (informativ) Aufstellung von Normen über Werkstoffe, die für die Herstellung von
Implantaten als geeignet befunden wurden…………………………………………………………………………..13
Anhang B (informativ) Aufstellung von Normen über Werkstoffe, die für artikulierende Flächen
von Implantaten als geeignet oder ungeeignet befunden wurden………………………………………….14
B.1 Geeignete Werkstoffkombinationen ……………………………………………………………………………………..14
B.2 Ungeeignete Werkstoffkombinationen für miteinander artikulierende Oberflächen………………..15
Anhang C (informativ) Aufstellung von Werkstoffen, die bei Implantaten für Metallkombinationen
an Kontaktflächen ohne Gelenkfunktion als geeignet oder ungeeignet befunden wurden ……..16
C.1 Geeignete Kombinationen ungleicher Metalle an nicht miteinander artikulierenden
Kontaktflächen…………………………………………………………………………………………………………………….16
C.2 Für nicht miteinander artikulierende Kontaktflächen ungeeignete Metallkombinationen………..16
Literaturhinweise …………………………………………………………………………………………………………………………….17
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG………………………………………………..19

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2007)

Abstract

ISO 21536:2007 provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

DIN EN ISO 21536:2009-08 (D)
Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere
Anforderungen an Implantate für den Kniegelenkersatz (ISO 21536:2007); Deutsche
Fassung EN ISO 21536:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………5
4 Beabsichtige Funktion …………………………………………………………………………………………………………..6
5 Konstruktionsmerkmale ………………………………………………………………………………………………………..6
5.1 Allgemeines ………………………………………………………………………………………………………………………….6
5.2 Stärke des ultrahochmolekularen Polyethylens (UHMWPE) bei tibialen und meniskalen
Komponenten ……………………………………………………………………………………………………………………….6
5.3 Oberflächenbearbeitung nichtartikulierender Bereiche metallischer
Kniegelenkkomponenten……………………………………………………………………………………………………….7
6 Werkstoffe …………………………………………………………………………………………………………………………….7
7 Designprüfung ………………………………………………………………………………………………………………………7
7.1 Allgemeines ………………………………………………………………………………………………………………………….7
7.2 Präklinische Bewertung…………………………………………………………………………………………………………7
7.2.1 Dauerbelastbarkeit der Tibiatrays von Kniegelenkkomponenten — zementiert und
nichtzementiert ……………………………………………………………………………………………………………………..7
7.2.2 Verschleißprüfung bei totalem Kniegelenkersatz……………………………………………………………………7
8 Herstellung……………………………………………………………………………………………………………………………8
9 Sterilisation …………………………………………………………………………………………………………………………..8
10 Verpackung …………………………………………………………………………………………………………………………..8
11 Bereitstellung von Informationen durch den Hersteller…………………………………………………………..8
11.1 Allgemeines ………………………………………………………………………………………………………………………….8
11.2 Bereitstellung von Informationen auf dem Etikett …………………………………………………………………..8
11.3 Konstruktive Kompatibilität der Komponenten ………………………………………………………………………8
11.4 Informationen für den Patienten…………………………………………………………………………………………….9
11.5 Kennzeichnung……………………………………………………………………………………………………………………..9
Anhang A (informativ) Prüfung des relativen Bewegungsumfanges von vollständig gekoppelten
Implantatkomponenten für den totalen Kniegelenkersatz ……………………………………………………..10
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG ……………………………………………….11

External limb prostheses and external orthoses – Requirements and test methods (ISO 22523:2006)

Abstract

 

ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:

• 06 03 – 06 15 Orthoses
• 06 18 – 06 27 Limb prostheses

It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.

This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

DIN EN ISO 22523:2007-04 (E)
External limb prostheses and external orthoses – Requirements and test methods
(ISO 22523:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….5
Introduction ……………………………………………………………………………………………………………………………………6
1 Scope ……………………………………………………………………………………………………………………………..7
2 Normative references ……………………………………………………………………………………………………..7
3 Terms and definitions ……………………………………………………………………………………………………..8
4 General requirements ……………………………………………………………………………………………………10
4.1 Risk management ………………………………………………………………………………………………………….10
4.2 Intended performance and technical documentation ……………………………………………………..11
4.3 Clinical evaluation …………………………………………………………………………………………………………11
4.4 Strength and related conditions of use ………………………………………………………………………….11
5 Requirements for materials ……………………………………………………………………………………………12
5.1 Flammability of materials and toxicity of combustion products ……………………………………..12
5.2 Biocompatibility, contaminants and residues ………………………………………………………………..13
5.2.1 General …………………………………………………………………………………………………………………………13
5.2.2 Contaminants and residues …………………………………………………………………………………………..13
5.3 Infection and microbiological contamination …………………………………………………………………13
5.4 Resistance to corrosion and degradation ………………………………………………………………………13
6 Noise and vibration ……………………………………………………………………………………………………….13
7 Electromagnetic compatibility (EMC) ……………………………………………………………………………..14
8 Electrical safety …………………………………………………………………………………………………………….14
8.1 Battery-powered prosthetic and orthotic devices …………………………………………………………..14
8.1.1 Battery housings and connections ………………………………………………………………………………..14
8.1.2 Charge level indicators ………………………………………………………………………………………………….14
8.2 Circuit protection ………………………………………………………………………………………………………….15
8.3 Electronic programmable systems ………………………………………………………………………………..15
8.4 Electrically heated blankets, pads and similar flexible heating appliances ……………………..15
8.5 Prosthetic and orthotic devices with skin contact electrodes …………………………………………15
8.6 Prosthetic and orthotic devices with radio equipment ……………………………………………………15
8.6.1 General …………………………………………………………………………………………………………………………15
8.6.2 Frequency spectrum of radio equipment ……………………………………………………………………….15
8.6.3 Operation of radio equipment by the user ……………………………………………………………………..15
9 Surface temperature ……………………………………………………………………………………………………..16
10 Sterility …………………………………………………………………………………………………………………………16
11 Design requirements ……………………………………………………………………………………………………..16
11.1 Safety of moving parts ………………………………………………………………………………………………….16
11.2 Safety of connections ……………………………………………………………………………………………………16
12 Mechanical requirements ………………………………………………………………………………………………16
12.1 Restrictions on use ……………………………………………………………………………………………………….16

12.2 Forces in soft tissues of the human body …………………………………………………………………….. 17
12.3 Ergonomic principles …………………………………………………………………………………………………… 17
13 Information supplied by the manufacturer ……………………………………………………………………. 17
13.1 General ……………………………………………………………………………………………………………………….. 17
13.2 Labelling ……………………………………………………………………………………………………………………… 18
13.3 Intended use ………………………………………………………………………………………………………………… 18
14 Packaging ……………………………………………………………………………………………………………………. 18
Annex A (informative) Guidance on methods of determining the strength of upper-limb prosthetic
devices ………………………………………………………………………………………………………………………… 19
Annex B (normative) Method of determining the mechanical properties of knee joint assemblies for
lower-limb orthotic devices ………………………………………………………………………………………….. 34
Annex C (informative) Guidance on methods of determining the flammability and toxicity of
combustion products of lower-limb prosthetic devices ………………………………………………… 47
Annex D (informative) Guidance on methods of establishing the force or moment required to
operate the control and actuating mechanisms on prosthetic and orthotic devices ………. 61
Annex E (informative) Reference to the essential principles of safety and performance of medical
devices in accordance with ISO/TR 16142 …………………………………………………………………….. 86
Bibliography ……………………………………………………………………………………………………………………………….. 88
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives …………………………………………………………………………………. 89
Figure A.1 — Test sample segment lengths ………………………………………………………………………………….. 21
Figure A.2 — Configuration of test 1 …………………………………………………………………………………………….. 22
Figure A.3 — Configuration of test 2 and test 4 …………………………………………………………………………….. 23
Figure A.4 — Configuration of test 3 and test 5 …………………………………………………………………………….. 23
Figure A.5 — Examples of test sample configurations …………………………………………………………………… 24
Figure B.1 — Example of a test rig design suitable for the application of the four-point loading
system ………………………………………………………………………………………………………………………… 40
Figure B.2 — Arrangements of the four-point loading system (continued on Figure B.3) ……………….. 41
Figure B.3 — Arrangements of the four-point loading system (continued from Figure B.2) …………….. 42
Figure B.4 — Test orientations for joint assemblies intended to restrain motion in four directions
mutually at right angles (see B.5.1) ………………………………………………………………………………. 43
Figure B.5 — Example of a bending moment/angular deflection curve: single-stage failure (see 3.17,
3.18 and 3.19) ………………………………………………………………………………………………………………. 44
Figure B.6 — Examples of a bending moment/angular deflection curve: two-stage failures (see 3.17,
3.18 and 3.19) ………………………………………………………………………………………………………………. 45
Figure C.1 — Test sample dimensions trans-femoral (above-knee) — Finished limb ……………………….. 54
Figure C.2 — Test sample dimensions trans-tibial (below-knee) — Finished limb …………………………… 55
Figure C.3 — Test sample dimensions trans-femoral (above-knee) — Socket former ………………………. 56

Figure C.4 — Test sample dimensions trans-tibial (below-knee) — Socket former ……………………………56
Figure C.5 — Radiant heat source test ……………………………………………………………………………………………57
Figure C.6 — Flaming ignition source test ……………………………………………………………………………………..58
Figure C.7 — Sample support frame and weighing platform ……………………………………………………………59
Figure D.1 — Bowden cable arrangement during test ……………………………………………………………………..75
Figure D.2 — Test set-up according to D.6.2 for sample category D.3.1 a) Orthotic knee joints with
locking mechanism ……………………………………………………………………………………………………….76
Figure D.3 — Test set-up according to D.6.3 for sample category D.3.1 b) Orthotic elbow joints with
locking mechanism ……………………………………………………………………………………………………….76
Figure D.4 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units with
locking mechanism (continued on Figure D.5) ……………………………………………………………….77
Figure D.5 — Test set-up according to D.6.4 for sample category D.3.1 c) Prosthetic knee units with
locking mechanism (continued from Figure D.4) ……………………………………………………………78
Figure D.6 — Test set-up according to D.6.5 for sample category D.3.1 d) Prosthetic elbow units
with locking mechanism ………………………………………………………………………………………………..78
Figure D.7 — Test set-up according to D.6.6 for sample category D.3.1 e) Prosthetic elbow units
with user-driven articulation ………………………………………………………………………………………….79
Figure D.8 — Test set-up according to D.6.7 for sample category D.3.1 f) Terminal devices with
built-in closing function ………………………………………………………………………………………………..80
Figure D.9 — Test set-up according to D.6.8 for sample category D.3.1 g) Terminal devices with
built-in opening function ……………………………………………………………………………………………….81
Figure D.10 — Test set-up according to D.6.9 for sample category D.3.1 h) Terminal devices with no
built-in closing or opening function, actuated by force application …………………………………82
Figure D.11 — Test set-up according to D.6.10 for sample category D.3.1 i) Terminal devices with
no built-in closing or opening function, actuated by torque application ………………………….83
Figure D.12 — Test set-up according to D.6.11 for sample category D.3.1 j) Terminal devices with
break-open feature for emergency situations …………………………………………………………………84
Figure D.13 — Test set-up according to D.6.12 for sample category D.3.1 k) Prosthetic devices with
fail-safe release unit, illustrated for a separable prosthetic adaptor plate ……………………….85
Table A.1 — Number of tests and test samples required …………………………………………………………………25
Table B.1 — Example of test report ………………………………………………………………………………………………..46
Table C.1 — Worked example of calculating the TTPD ……………………………………………………………………60
Table D.1 — Parameters of the test set-up for sample category D.3.1 a) ………………………………………….66
Table D.2 — Parameters of the test set-up for sample category D.3.1 c) ………………………………………….68
Table D.3 — Details of the test report ……………………………………………………………………………………………..73
Table D.4 — Values of actuating/operating force (and displacement) and moment measured on
different categories of test sample …………………………………………………………………………………74
Table E.1 — Correspondence between this International Standard and the essential principles of
ISO/TR 16142 ……………………………………………………………………………………………………………….. 87

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2006)

Abstract

ISO 22675:2006 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life.

In addition, ISO 22675:2006 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.

DIN EN ISO 22675:2007-04 (E)
Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test
methods (ISO 22675:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….6
Introduction ……………………………………………………………………………………………………………………………………7
1 Scope ……………………………………………………………………………………………………………………………..8
2 Normative references ……………………………………………………………………………………………………..9
3 Terms and definitions ……………………………………………………………………………………………………..9
4 Designations and symbols of test forces …………………………………………………………………………9
5 Strength and related performance requirements and conditions of use ………………………….10
6 Coordinate system and test configurations ……………………………………………………………………11
6.1 General …………………………………………………………………………………………………………………………11
6.2 Origin and axes of the coordinate system ……………………………………………………………………..11
6.3 Reference points …………………………………………………………………………………………………………..12
6.4 Test force F …………………………………………………………………………………………………………………..13
6.5 Line of application of test force F …………………………………………………………………………………..13
6.6 Lines of action of resultant reference forces FR1 and FR2 ……………………………………………..13
6.7 Longitudinal axis of the foot and effective ankle joint centre ………………………………………….13
6.7.1 General …………………………………………………………………………………………………………………………13
6.7.2 Longitudinal axis of the foot ………………………………………………………………………………………….13
6.7.3 Effective ankle-joint centre, CA ……………………………………………………………………………………..14
7 Test loading conditions and test loading levels ……………………………………………………………..15
7.1 Test loading conditions …………………………………………………………………………………………………15
7.2 Test loading levels ………………………………………………………………………………………………………..15
8 Values of test forces, dimensions and cycles ………………………………………………………………..16
9 Compliance …………………………………………………………………………………………………………………..23
9.1 General …………………………………………………………………………………………………………………………23
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 …………………………24
9.2.1 Arrangements for testing ………………………………………………………………………………………………24
9.2.2 Requirements for claiming compliance ………………………………………………………………………….24
9.3 Number of tests and test samples required to claim compliance with this International
Standard ……………………………………………………………………………………………………………………….24
9.4 Multiple use of test samples ………………………………………………………………………………………….25
9.4.1 General …………………………………………………………………………………………………………………………25
9.4.2 Restriction …………………………………………………………………………………………………………………….25
9.5 Testing at particular test loading levels not specified in this International Standard ……….25
10 Test samples …………………………………………………………………………………………………………………26
10.1 Selection of test samples ………………………………………………………………………………………………26
10.1.1 General …………………………………………………………………………………………………………………………26
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot ……………………….26
10.2 Types of test sample ……………………………………………………………………………………………………..27
10.2.1 Complete structure ……………………………………………………………………………………………………….27

10.2.2 Partial structure …………………………………………………………………………………………………………… 27
10.3 Preparation of test samples …………………………………………………………………………………………. 27
10.4 Identification of test samples ……………………………………………………………………………………….. 28
10.5 Alignment of test samples ……………………………………………………………………………………………. 28
10.6 Worst-case alignment position of test samples …………………………………………………………….. 28
11 Responsibility for test preparation ……………………………………………………………………………….. 30
12 Test submission document ………………………………………………………………………………………….. 31
12.1 General requirements ………………………………………………………………………………………………….. 31
12.2 Information required for test samples …………………………………………………………………………… 31
12.3 Information required for tests ………………………………………………………………………………………. 32
12.3.1 General ……………………………………………………………………………………………………………………….. 32
12.3.2 For all tests ………………………………………………………………………………………………………………….. 32
12.3.3 For the static proof test and the static ultimate strength test ………………………………………… 32
12.3.4 For the static ultimate strength test ……………………………………………………………………………… 32
12.3.5 For the cyclic test ………………………………………………………………………………………………………… 32
13 Equipment …………………………………………………………………………………………………………………… 33
13.1 General ……………………………………………………………………………………………………………………….. 33
13.2 End attachments ………………………………………………………………………………………………………….. 33
13.2.1 General ……………………………………………………………………………………………………………………….. 33
13.2.2 Proof test of end attachments ………………………………………………………………………………………. 33
13.3 Jig (optional) ……………………………………………………………………………………………………………….. 35
13.4 Test equipment ……………………………………………………………………………………………………………. 35
13.4.1 Test equipment to perform static heel and forefoot loading ………………………………………….. 35
13.4.2 Test equipment to perform cyclic loading …………………………………………………………………….. 37
14 Accuracy ……………………………………………………………………………………………………………………… 44
14.1 General ……………………………………………………………………………………………………………………….. 44
14.2 Accuracy of equipment ………………………………………………………………………………………………… 44
14.3 Accuracy of procedure ………………………………………………………………………………………………… 45
15 Test principles …………………………………………………………………………………………………………….. 45
15.1 General ……………………………………………………………………………………………………………………….. 45
15.2 Static test procedure ……………………………………………………………………………………………………. 46
15.3 Cyclic test procedure …………………………………………………………………………………………………… 46
16 Test procedures …………………………………………………………………………………………………………… 46
16.1 Test loading requirements ……………………………………………………………………………………………. 46
16.1.1 Preparation for test loading ………………………………………………………………………………………….. 46
16.1.2 Test loading conditions ……………………………………………………………………………………………….. 50
16.2 Static proof test …………………………………………………………………………………………………………… 50
16.2.1 Test method ………………………………………………………………………………………………………………… 50
16.2.2 Performance requirement …………………………………………………………………………………………….. 52
16.2.3 Compliance conditions ………………………………………………………………………………………………… 52
16.3 Static ultimate strength test …………………………………………………………………………………………. 54
16.3.1 Test method ………………………………………………………………………………………………………………… 54
16.3.2 Performance requirements …………………………………………………………………………………………… 57
16.3.3 Compliance conditions ………………………………………………………………………………………………… 57
16.4 Cyclic test ……………………………………………………………………………………………………………………. 59
16.4.1 Test method ………………………………………………………………………………………………………………… 59
16.4.2 Performance requirements …………………………………………………………………………………………… 61
16.4.3 Compliance conditions ………………………………………………………………………………………………… 62
17 Test laboratory/facility log ……………………………………………………………………………………………. 65
17.1 General requirements ………………………………………………………………………………………………….. 65
17.2 Specific requirements ………………………………………………………………………………………………….. 65
18 Test report …………………………………………………………………………………………………………………… 65
18.1 General requirements ………………………………………………………………………………………………….. 65
18.2 Specific requirements ………………………………………………………………………………………………….. 66

18.3 Options …………………………………………………………………………………………………………………………66
19 Classification and designation ………………………………………………………………………………………66
19.1 General …………………………………………………………………………………………………………………………66
19.2 Examples of classification and designation …………………………………………………………………..66
20 Labelling ……………………………………………………………………………………………………………………….67
20.1 General …………………………………………………………………………………………………………………………67
20.2 Use of mark “*)” and warning symbol …………………………………………………………………………….68
20.3 Examples of label layout ……………………………………………………………………………………………….68
20.4 Label placement ……………………………………………………………………………………………………………69
Annex A (informative) Reference data for the specification of the test loading conditions and test
loading levels of this International Standard ………………………………………………………………….70
Annex B (informative) Guidance on the application of an alternative static ultimate strength test …..78
Annex C (informative) Guidance on the application of an additional test loading level P6 ………………79
Annex D (informative) Summary of the records to be entered in the test laboratory/facility log ………81
Annex E (informative) Information on Technical Report ISO/TR 22676 [1] ………………………………………87
Annex F (informative) Reference to the essential principles of safety and performance of medical
devices according to ISO/TR 16142 ……………………………………………………………………………….98
Bibliography …………………………………………………………………………………………………………………………………99
Annex ZA (informative) Clauses of this European Standard addressing essential requirements
Figure 1 — Coordinate system with reference parameters ………………………………………………12
Figure 2 — Determination of longitudinal axis of foot (see 6.7.2) and effective ankle-joint centre CA
(see 6.7.3) ……………………………………………………………………………………………………………………..14
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 ………………………………………………………21
Figure 4 — Illustration of specific set-up of left-sided test sample with top load application point PT 30
Figure 5 — Diagrammatic view of test equipment according to 13.4.1 and 13.4.2 with test sample …..42
Figure 6 — Profiles of test force Fc(t) and tilting angle (t) as synchronized functions of time,
determining the loading condition of the cyclic test of this International Standard …………43
Figure 7 — Test force Fc() of test loading level P5 as function of tilting angle (t) of foot platform …….44
Figure 8 — Preparation for test loading of static test procedure [see 16.1.1 a)] ……………………………….49
Figure 9 — Flowchart for the static proof test specified in 16.2.1 …………………………………………………….53
Figure 10 — Flowchart for the static ultimate strength test specified in 16.3.1 …………………………………58
Figure 11 — Flowchart for the cyclic test specified in 16.4.1 Continued on Figure 12 ………………………63
Figure 12 — Flowchart for the cyclic test specified in 16.4.1 Continued from Figure 11 …………………..64
Figure 13 — General concept for the label layout ……………………………………………………………………………67
Figure 14 — Models for the label layout ………………………………………………………………………………………….68
Figure A.1 — Illustration of different components of loading ………………………………………………………….76

Figure A.2 — Illustration of the dependence of the position of the top load application point PT on
the foot length L — (see A.2.2.3) ……………………………………………………………………………………. 77
Figure E.1 — Effect of f-position of tilting axis TA of foot platform on the elevation E of the foot at
the instants of heel contact and toe-off ………………………………………………………………………… 90
Figure E.2 — Effect of u-position of tilting axis TA of foot platform on the A/P displacement f of the
foot at the instant of toe-off ………………………………………………………………………………………….. 91
Figure E.3 — Illustration of the effect of A-P displacement f on the angular movement of the test
sample about the top load application point PT ……………………………………………………………. 92
Figure E.4 — Illustration of possibilities of 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 ………………………………………………………………………………………… 95
Figure E.5 — Illustration of the effect of a fixed compromise offset uTA, C of the tilting axis TA of
the foot platform on the A-P displacement f at the foot [see E.3.4.2 c) 2)] ………………………. 96
Table 1 — Designations and symbols of test forces ………………………………………………………………………… 9
Table 2 — Categories of strength addressed in this International Standard, together with the related
performance requirements and test methods for their verification ………………………………… 10
Table 3 — Test forces and relevant references ……………………………………………………………………………… 16
Table 4 — Values of bottom offsets fB1, L (heel) and fB2, L (forefoot) for given values of foot length
L, relevant to the design and/or adjustment of the rigid foot dummy required to simulate
or other provisions of EU Directives …………………………………………………………………………… 100
the effective lever arms of an ankle-foot device or foot unit in the proof test of end attachments
(see 13.2.2) ………………………………………………………………………………………………………………….. 17
Table 5 — Test forces of the proof test of end attachments for test loading levels P5, P4 and P3
(see 13.2.1) ………………………………………………………………………………………………………………….. 17
Table 6 — Total length of test samples and segmental lengths of end attachments ……………………….. 18
Table 7 — Coordinates of top load application point PT and tilting axis TA of foot platform based on
given values of foot length L, for all test loading levels ………………………………………………… 19
Table 8 — Angles of toe-out position of foot and specific tilting positions of foot platform, for all
test loading levels ……………………………………………………………………………………………………….. 19
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) …………………………………………………… 20
Table 10 — Thresholds according to Figure 3 for specification of the application of the loading
profile of the cyclic test ……………………………………………………………………………………………….. 22
Table 11 — Data specifying the values of tilting angle (t) and test force Fc(t) illustrated in Figure 6
in 30 ms time increments for guidance on their application ………………………………………….. 23
Table 12 — Number of tests and test samples required to claim compliance with this International
Standard ……………………………………………………………………………………………………………………… 26
Table 13 — Option for end attachments of specific design ……………………………………………………………. 33
Table A.1 — Magnitudes of resultant reference forces FR1x and FR2x ………………………………………….. 73
Table C.1 — Test forces of the proof test of end attachments for test loading level P6 (see 13.2.2.1) 79

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) ……………………………………………………………………….80
Table E.1 — Contents of ISO/TR 22676 and list of corresponding clauses/subclauses of this
International Standard, in which selected items are dealt with ……………………………………….88
Table E.2 — Possibilities of 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 97
Table F.1 — Correspondence between this International Standard and the essential principles of
ISO/TR 16142 ………………………………………………………………………………………………………………..98