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BS EN ISO 10328:2016

BS EN ISO 10328:2016

$215.11

Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods

Published By Publication Date Number of Pages
BSI 2016 156
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IMPORTANT This International Standard is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to ISO 22675:2016.

WARNING This International Standard is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.

This International Standard specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.

The tests described in this International Standard comprise

  • principal static and cyclic tests for all components;

  • a separate static test in torsion for all components;

  • separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;

  • a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;

  • separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.

The tests described in this International Standard apply to specific types of ankle-disarticulation prostheses (see NOTE 2), to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses (see NOTE 3).

NOTE 1 The tests can be performed on complete structures, on part structures or on individual components.

NOTE 2 The tests only apply to ankle-disarticulation prostheses which include (foot) components of prosthetic ankle-foot devices taken from the normal production line.

NOTE 3 The distal part comprises the knee unit, the ankle-foot device and all parts between. Tests on hip units are described in ISO 15032.

PDF Catalog

PDF Pages PDF Title
4 European foreword
5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
Table ZA.1 — Correspondence between this European standard and Annex I of Directive 93/42/EEC [OJ L 169]
11 Foreword
12 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
4 Designations and symbols of test forces and moments
15 5 Strength and related performance requirements and conditions of use
17 6 Coordinate systems and test configurations
6.1 General
6.2 Axes of coordinate systems
6.3 Reference planes
6.3.1 General
6.3.2 Top reference plane, T
6.3.3 Knee reference plane, K
18 6.3.4 Ankle reference plane, A
6.3.5 Bottom reference plane, B
19 6.4 Reference points
20 6.5 Test force
6.6 Load line
6.7 Longitudinal axis of the foot and effective joint centres and centrelines
6.7.1 General
6.7.2 Longitudinal axis of the foot
6.7.3 Effective ankle-joint centre
22 6.7.4 Effective ankle-joint centreline
6.7.5 Effective knee-joint centreline
23 6.7.6 Effective knee-joint centre
6.8 Reference distances
6.8.1 Offsets
6.8.2 Combined offsets
6.8.3 Effective lever arms LA and LK
6.8.4 Distance LBT
7 Test loading conditions and test loading levels
7.1 Test loading conditions
7.1.1 General
24 7.1.2 Test loading conditions of principal structural tests
7.1.3 Test loading conditions of separate structural tests
7.2 Test loading levels
25 8 Values of test loads, dimensions and cycles
32 9 Compliance
9.1 General
33 9.2 Selection of tests required to claim compliance with this International Standard
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
9.3.1 General
9.3.2 Particular arrangements concerning the ankle-foot device or foot unit
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
34 9.4 Number of tests and test samples required to claim compliance with this International Standard
9.5 Multiple use of test samples
9.5.1 General
9.5.2 Restriction
35 9.6 Testing at particular test loading levels not specified in this International Standard
37 10 Test samples
10.1 Selection of test samples
10.1.1 General
38 10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot
39 10.2 Types of test samples
10.2.1 Complete structure
41 10.2.2 Partial structure
10.2.3 Any other structure
10.3 Preparation of test samples
42 10.4 Identification of test samples
43 10.5 Alignment of test samples
10.5.1 Test samples for principal tests and separate tests on knee locks
10.5.2 Test samples for separate tests on ankle-foot devices and foot units
10.5.3 Test samples for separate static ultimate strength tests in maximum knee flexion for knee joints and associated parts
44 10.5.4 Test samples for separate tests on knee locks
10.6 Worst-case alignment position of test samples
45 11 Responsibility for test preparation
46 12 Test submission document
12.1 General requirements
47 12.2 Information required for test samples
12.2.1 All test samples
12.2.2 Test samples for tests on ankle-foot devices and foot units
12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints and associated parts
12.3 Information required for tests
12.3.1 General
12.3.2 For all tests
48 12.3.3 For static tests in torsion and on ankle-foot devices and foot units
12.3.4 For static ultimate strength tests
12.3.5 For cyclic tests
12.3.6 For tests in torsion
12.3.7 For tests on ankle-foot devices and foot units
49 13 Equipment
13.1 General
13.2 Equipment for the principal tests specified in 16.2 and 16.3
13.2.1 End attachments
51 13.2.2 Jig (optional)
52 13.2.3 Test equipment
54 13.3 Equipment for the separate static test in torsion specified in 17.1
13.3.1 Test equipment
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2
13.4.1 Test equipment
58 13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3
13.5.1 Extension pieces
13.5.2 Test equipment to perform static compression loading – (Compression testing machine or other equipment)
13.6 Equipment for the separate tests on knee locks specified in 17.4
13.6.1 End attachments
13.6.2 Jig (optional)
13.6.3 Test equipment
59 14 Accuracy
14.1 General
14.2 Accuracy of equipment
14.3 Accuracy of procedure
60 15 Test principles
15.1 General
15.2 Static test procedure
15.3 Cyclic test procedure
16 Test procedures – Principal structural tests
16.1 Test loading requirements
16.1.1 Preparation for test loading
16.1.2 Application of test loading
62 16.2 Principal static test procedure
16.2.1 Principal static proof test
67 16.2.2 Principal static ultimate strength test
71 16.3 Principal cyclic test procedure
16.3.1 General requirements
16.3.2 Test method
75 16.3.3 Performance requirements
76 16.3.4 Compliance conditions
80 17 Test procedures — Separate structural tests
17.1 Separate static test in torsion
17.1.1 General
17.1.2 Purpose of test
17.1.3 Test method
82 17.1.4 Performance requirements
17.1.5 Compliance conditions
84 17.2 Separate tests on ankle-foot devices and foot units
17.2.1 General
17.2.2 Purpose of tests
17.2.3 Separate static proof test for ankle-foot devices and foot units
88 17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units
93 17.2.5 Separate cyclic test for ankle-foot devices and foot units
98 17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts
17.3.1 General
17.3.2 Purpose of test
17.3.3 Applicability of the test to specific test samples
99 17.3.4 Test method
100 17.3.5 Performance requirement
17.3.6 Compliance conditions
101 17.4 Separate tests on knee locks
17.4.1 General
102 17.4.2 Purpose of tests
17.4.3 Separate static proof test for knee locks
106 17.4.4 Separate static ultimate strength test for knee locks
108 17.4.5 Separate cyclic test for knee locks
117 18 Test laboratory/facility log
18.1 General requirements
18.2 Specific requirements
19 Test report
19.1 General requirements
118 19.2 Specific requirements
19.3 Options
20 Classification and designation
20.1 General
20.2 Examples of classification and designation
119 21 Labelling
21.1 General
120 21.2 Use of mark “*)” and warning symbol
21.3 Examples of label layout
21.4 Label placement
122 Annex A (informative) Description of internal loads and their effects
126 Annex B (informative) Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests
130 Annex C (informative) Guidance on the application of an alternative static ultimate strength test
131 Annex D (normative) Guidance on the application of an additional test loading levels P6, P7 and P8
134 Annex E (informative) Summary of the records to be entered in the test laboratory/facility log
149 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
151 Annex G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142
152 Bibliography

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BS EN ISO 10328:2016
$215.11