EN ISO 10328:2006

SLOVENSKI STANDARD
01-december-2006
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Prosthetics - Structural testing of lower-limb prostheses - Requirements and test
methods (ISO 10328:2006)
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen
und Prüfverfahren (ISO 10328:2006)
Protheses - Essais portant sur la structure des protheses de membres inférieurs -
Exigences et méthodes d'essai (ISO 10328:2006)
Ta slovenski standard je istoveten z: EN ISO 10328:2006
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10328
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.040.40
English Version
Prosthetics - Structural testing of lower-limb prostheses -
Requirements and test methods (ISO 10328:2006)
Prothèses - Essais portant sur la structure des prothèses Prothetik - Prüfung der Struktur von Prothesen der unteren
de membres inférieurs - Exigences et méthodes d'essai Gliedmaßen - Anforderungen und Prüfverfahren (ISO
(ISO 10328:2006) 10328:2006)
This European Standard was approved by CEN on 13 April 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
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Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10328:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 10328:2006) has been prepared by Technical Committee ISO/TC 168
"Prosthetics and orthotics" in collaboration with Technical Committee CEN/TC 293 "Assistive
products for persons with disability", the secretariat of which is held by SIS.

This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2007, and conflicting national standards shall
be withdrawn at the latest by April 2007.

This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 10328:2006 has been approved by CEN as EN ISO 10328:2006 without any
modifications.
ANNEX ZA
(informative)
Clauses of this European Standard addressing essential requirements
or other provisions of EU Directives.

This European standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association and supports corresponding essential
requirements of EU Directive 93/42/EEC concerning medical devices.

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

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

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

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

Corresponding Essential Comments
Clauses of this European
Requirements of Directive
Standard
93/42/EEC
5; 6; 7; 8; 9; 10; 15; 16; 17 2, 4, 12.7.1
5; 20; 21 9.1
5; 20; 21 13.1 Essential requirement 13.1 is not fully
covered here; only the aspects of
classification are addressed.
21 13.3 k)
INTERNATIONAL ISO
STANDARD 10328
First edition
2006-10-01
Prosthetics — Structural testing of lower-
limb prostheses — Requirements and
test methods
Prothèses — Essais portant sur la structure des prothèses de membres
inférieurs — Exigences et méthodes d'essai

Reference number
ISO 10328:2006(E)
©
ISO 2006
ISO 10328:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 10328:2006(E)
Contents Page
Foreword. ix
Introduction . x
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Designations and symbols of test forces and moments. 3
5 Strength and related performance requirements and conditions of use. 3
6 Coordinate systems and test configurations . 5
6.1 General. 5
6.2 Axes of coordinate systems . 5
6.3 Reference planes . 5
6.3.1 General. 5
6.3.2 Top reference plane, T. 5
6.3.3 Knee reference plane, K. 5
6.3.4 Ankle reference plane, A. 5
6.3.5 Bottom reference plane, B . 6
6.4 Reference points. 8
6.5 Test force. 8
6.6 Load line . 8
6.7 Longitudinal axis of the foot and effective joint centres and centrelines . 8
6.7.1 General. 8
6.7.2 Longitudinal axis of the foot. 8
6.7.3 Effective ankle-joint centre . 8
6.7.4 Effective ankle-joint centreline. 10
6.7.5 Effective knee-joint centreline. 10
6.7.6 Effective knee-joint centre . 11
6.8 Reference distances. 11
6.8.1 Offsets. 11
6.8.2 Combined offsets. 11
6.8.3 Effective lever arms L and L . 11
A K
6.8.4 Distance L . 11
BT
7 Test loading conditions and test loading levels. 11
7.1 Test loading conditions. 11
7.1.1 General. 11
7.1.2 Test loading conditions of principal structural tests. 12
7.1.3 Test loading conditions of separate structural tests . 12
7.2 Test loading levels. 12
8 Values of test loads, dimensions and cycles . 13
9 Compliance. 21
9.1 General. 21
9.2 Selection of tests required to claim compliance with this International Standard. 21
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. 21
9.3.1 General. 21
9.3.2 Particular arrangements concerning the ankle-foot device or foot unit. 21
9.3.3 Particular arrangements and requirements concerning the part required to connect the
ankle-foot device or foot unit to the remainder of the prosthetic structure. 21
ISO 10328:2006(E)
9.4 Number of tests and test samples required to claim compliance with this International
Standard. 22
9.5 Multiple use of test samples . 22
9.5.1 General . 22
9.5.2 Restriction. 23
9.6 Testing at particular test loading levels not specified in this International Standard. 23
10 Test samples. 25
10.1 Selection of test samples . 25
10.1.1 General . 25
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot. 25
10.2 Types of test samples. 26
10.2.1 Complete structure . 26
10.2.2 Partial structure. 28
10.2.3 Any other structure. 28
10.3 Preparation of test samples. 28
10.4 Identification of test samples. 29
10.5 Alignment of test samples . 30
10.5.1 Test samples for principal tests and separate tests on knee locks . 30
10.5.2 Test samples for separate tests on ankle-foot devices and foot units . 30
10.5.3 Test samples for separate static ultimate strength tests in maximum knee flexion for knee
joints and associated parts. 31
10.5.4 Test samples for separate tests on knee locks . 31
10.6 Worst-case alignment position of test samples . 32
11 Responsibility for test preparation . 32
12 Test submission document. 33
12.1 General requirements . 33
12.2 Information required for test samples . 34
12.2.1 All test samples. 34
12.2.2 Test samples for tests on ankle-foot devices and foot units . 34
12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints
and associated parts . 34
12.3 Information required for tests. 35
12.3.1 General . 35
12.3.2 For all tests . 35
12.3.3 For static tests in torsion and on ankle-foot devices and foot units. 35
12.3.4 For static ultimate strength tests . 35
12.3.5 For cyclic tests . 35
12.3.6 For tests in torsion. 35
12.3.7 For tests on ankle-foot devices and foot units . 36
13 Equipment. 36
13.1 General . 36
13.2 Equipment for the principal tests specified in 16.2 and 16.3 . 36
13.2.1 End attachments . 36
13.2.2 Jig (optional). 38
13.2.3 Test equipment. 38
13.3 Equipment for the separate static test in torsion specified in 17.1 . 40
13.3.1 Test equipment. 40
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 . 40
13.4.1 Test equipment. 40
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee
joints and associated parts specified in 17.3.44
13.5.1 Extension pieces. 44
13.5.2 Test equipment to perform static compression loading – (Compression testing machine
or other equipment) . 44
13.6 Equipment for the separate tests on knee locks specified in 17.4 . 44
13.6.1 End attachments . 44
13.6.2 Jig (optional). 44
13.6.3 Test equipment. 44
iv © ISO 2006 – All rights reserved

ISO 10328:2006(E)
14 Accuracy. 45
14.1 General. 45
14.2 Accuracy of equipment . 45
14.3 Accuracy of procedure. 45
15 Test principles. 46
15.1 General. 46
15.2 Static test procedure . 46
15.3 Cyclic test procedure . 46
16 Test procedures – Principal structural tests . 46
16.1 Test loading requirements. 46
16.1.1 Preparation for test loading. 46
16.1.2 Application of test loading. 46
16.2 Principal static test procedure . 48
16.2.1 Principal static proof test. 48
16.2.2 Principal static ultimate strength test. 53
16.3 Principal cyclic test procedure. 57
16.3.1 General requirements. 57
16.3.2 Test method. 57
16.3.3 Performance requirements . 61
16.3.4 Compliance conditions . 61
17 Test procedures – Separate structural tests . 65
17.1 Separate static test in torsion . 65
17.1.1 General. 65
17.1.2 Purpose of test. 65
17.1.3 Test method. 65
17.1.4 Performance requirements . 67
17.1.5 Compliance conditions . 67
17.2 Separate tests on ankle-foot devices and foot units . 69
17.2.1 General. 69
17.2.2 Purpose of tests. 69
17.2.3 Separate static proof test for ankle-foot devices and foot units . 69
17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units . 73
17.2.5 Separate cyclic test for ankle-foot devices and foot units. 78
17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and
associated parts. 83
17.3.1 General. 83
17.3.2 Purpose of test. 83
17.3.3 Applicability of the test to specific test samples . 83
17.3.4 Test method. 84
17.3.5 Performance requirement . 84
17.3.6 Compliance conditions . 85
17.4 Separate tests on knee locks . 86
17.4.1 General. 86
17.4.2 Purpose of tests. 86
17.4.3 Separate static proof test for knee locks . 86
17.4.4 Separate static ultimate strength test for knee locks . 90
17.4.5 Separate cyclic test for knee locks. 92
18 Test laboratory/facility log . 101
18.1 General requirements. 101
18.2 Specific requirements . 101
19 Test report . 101
19.1 General requirements. 101
19.2 Specific requirements . 102
19.3 Options . 102
20 Classification and designation. 102
20.1 General. 102
20.2 Examples of classification and designation . 102
ISO 10328:2006(E)
21 Labelling. 103
21.1 General . 103
21.2 Use of mark "*)" and warning symbol. 104
21.3 Examples of label layout . 104
21.4 Label placement . 104
Annex A (informative) Description of internal loads and their effects. 106
Annex B (informative) Reference data for the specification of test loading conditions and test
loading levels of principal cyclic tests . 110
Annex C (informative) Guidance on the application of an alternative static ultimate strength test . 114
Annex D (informative) Guidance on the application of an additional test loading level P6. 115
Annex E (informative) Summary of the records to be entered in the test laboratory/facility log. 118
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. 133
Annex G (informative) Reference to the essential principles of safety and performance of medical
devices according to ISO/TR 16142 . 135
Bibliography . 136

Figure 1 — Coordinate systems for right and left-sided application. 6
Figure 2 — Coordinate systems according to Figure 1 with reference planes . 6
Figure 3 — Specific configuration with u = 0, showing coordinate systems with reference planes
B
(see Figures 1 and 2), reference lines, reference points and test force, F, for right and left-
sided application. 7
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 S (see 6.8.2) for test loading condition II [see 7.1.2 b)]. 9
B
Figure 5 — Position of effective knee-joint centreline for prosthetic knee units of different types . 10
Figure 6 — Application of a specific test configuration with u = 0 to a left-sided sample specified
B
in 10.2.1 . 27
Figure 7 — Position of foot in test equipment (see 10.5.2, 13.4 and 17.2). 30
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). 31
Figure 9 — Load cycle parameters for the principal cyclic test.39
Figure 10 — Load cycle parameters for the separate cyclic test for ankle-foot devices and foot
units. 43
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). 47
Figure 12 — Method of calculating offsets at any height u = u (see 16.1.1). 48
x
Figure 13 — Flowchart for the principal static proof test, specified in 16.2.1.1 . 52
Figure 14 — Flowchart for the principal static ultimate strength test, specified in 16.2.2.1. 56
Figure 15 — Flowchart for the principal cyclic test, specified in 16.3.2 Continued on Figures 16 and
17 . 62
Figure 16 — Flowchart for the principal cyclic test, specified in 16.3.2 Continued from Figure 15
and continued on Figure 17 . 63
Figure 17 — Flowchart for the principal cyclic test, specified in 16.3.2 Continued from Figure 16. 64
vi © ISO 2006 – All rights reserved

ISO 10328:2006(E)
Figure 18 — Flowchart for the separate static test in torsion, specified in 17.1.3. 68
Figure 19 — Flowchart for the separate static proof test for ankle-foot devices and foot units,
specified in 17.2.3.1 . 72
Figure 20 — Flowchart for the separate static ultimate strength test for ankle-foot devices
and foot units, specified in 17.2.4.1 . 77
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. 81
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. 82
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 . 85
Figure 24 — Flowchart for the separate static proof test for knee locks, specified in 17.4.3.1. 89
Figure 25 — Flowchart for the separate static ultimate strength test for knee locks, specified in
17.4.4.1 . 92
Figure 26 — Flowchart for the separate cyclic test for knee locks, specified in 17.4.5.1 Continued
on Figures 27 and 28. 98
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 . 99
Figure 28 — Flowchart for the separate cyclic test for knee locks, specified in 17.4.5.1 Continued
from Figure 27. 100
Figure 29 — General concept for the label layout. 103
Figure 30 — Models for the label layout. 105
Figure A.1 — Test loading condition I [see 7.1.2 a)] . 108
Figure A.2 — Test loading condition II [see 7.1.2 b)] . 109

Table 1 — Designations and symbols of test forces and moments. 3
Table 2 — Categories of strength addressed in this International Standard, together with the
related performance requirements and test methods for their verification . 4
Table 3 — Test loads and relevant references. 14
Table 4 — Test forces of the proof test of end attachments for test loading levels P5, P4 and P3
(see 13.2.1.2). 15
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). 15
Table 6 — Values of offsets for all principal tests (see 16.2 and 16.3). 16
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) . 16
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). 17
Table 9 — Twisting moments of the separate static test in torsion (see 17.1). 18
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) . 18
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) . 19
ISO 10328:2006(E)
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). 19
Table 13 — Offsets of all separate tests on knee locks, for test loading levels P5, P4 and P3 (see
17.4) . 20
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). 20
Table 15 — Tests required to claim compliance with this International Standard for prosthetic
structures representing complete assemblies, partial assemblies or individual
components. 23
Table 16 — Number of tests and test samples required to claim compliance with this
International Standard . 24
Table 17 — Option for end attachments of specific design .37
Table A.1 — Positive internal forces and moments with descriptions of their effects. 107
Table B.1 — Values of ankle and knee moments related to test force F = F for different test
cr
loading conditions and test loading levels of principal cyclic tests . 111
Table B.2 — Calculated values of axial force and twisting moment related to test force F = F
cr
for different test loading conditions and test loading levels of principal cyclic tests. 111
Table B.3 — Values of ankle and knee moments related to test force F = F for different test
cmax
loading conditions and test loading levels of principal cyclic tests . 112
Table B.4 — Calculated values of axial force and twisting moment related to test force F = F
cmax
for different test loading conditions and test loading levels of principal cyclic tests. 112
Table D.1 — Test forces of the proof test of end attachments for test loading level P6
(see 13.2.1.2) . 116
Table D.2 — Test forces of all principal tests and p
...