ISO 10328:2016
Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
IMPORTANT - ISO 10328:2016 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 - ISO 10328:2016 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.
ISO 10328:2016 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Designations and symbols of test forces and moments
5 Strength and related performance requirements and conditions of use
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
6.3.4 Ankle reference plane, A
6.3.5 Bottom reference plane, B
6.4 Reference points
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
6.7.4 Effective ankle-joint centreline
6.7.5 Effective knee-joint centreline
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
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
8 Values of test loads, dimensions and cycles
9 Compliance
9.1 General
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
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
9.6 Testing at particular test loading levels not specified in this International Standard
10 Test samples
10.1 Selection of test samples
10.1.1 General
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot
10.2 Types of test samples
10.2.1 Complete structure
10.2.2 Partial structure
10.2.3 Any other structure
10.3 Preparation of test samples
10.4 Identification of test samples
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
10.5.4 Test samples for separate tests on knee locks
10.6 Worst-case alignment position of test samples
11 Responsibility for test preparation
12 Test submission document
12.1 General requirements
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
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
13 Equipment
13.1 General
13.2 Equipment for the principal tests specified in 16.2 and 16.3
13.2.1 End attachments
13.2.2 Jig (optional)
13.2.3 Test equipment
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
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
14 Accuracy
14.1 General
14.2 Accuracy of equipment
14.3 Accuracy of procedure
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
16.2 Principal static test procedure
16.2.1 Principal static proof test
16.2.2 Principal static ultimate strength test
16.3 Principal cyclic test procedure
16.3.1 General requirements
16.3.2 Test method
16.3.3 Performance requirements
16.3.4 Compliance conditions
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
17.1.4 Performance requirements
17.1.5 Compliance conditions
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
17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units
17.2.5 Separate cyclic test for ankle-foot devices and foot units
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
17.3.4 Test method
17.3.5 Performance requirement
17.3.6 Compliance conditions
17.4 Separate tests on knee locks
17.4.1 General
17.4.2 Purpose of tests
17.4.3 Separate static proof test for knee locks
17.4.4 Separate static ultimate strength test for knee locks
17.4.5 Separate cyclic test for knee locks
18 Test laboratory/facility log
18.1 General requirements
18.2 Specific requirements
19 Test report
19.1 General requirements
19.2 Specific requirements
19.3 Options
20 Classification and designation
20.1 General
20.2 Examples of classification and designation
21 Labelling
21.1 General
21.2 Use of mark “*)” and warning symbol
21.3 Examples of label layout
21.4 Label placement
Annex A (informative) Description of internal loads and their effects
Annex B (informative) Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests
Annex C (informative) Guidance on the application of an alternative static ultimate strength test
Annex D (normative) Guidance on the application of an additional test loading levels P6, P7 and P8
Annex E (informative) Summary of the records to be entered in the test laboratory/facility log
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
Annex G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Designations and symbols of test forces and moments
5 Strength and related performance requirements and conditions of use
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
6.3.4 Ankle reference plane, A
6.3.5 Bottom reference plane, B
6.4 Reference points
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
6.7.4 Effective ankle-joint centreline
6.7.5 Effective knee-joint centreline
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
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
8 Values of test loads, dimensions and cycles
9 Compliance
9.1 General
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
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
9.6 Testing at particular test loading levels not specified in this International Standard
10 Test samples
10.1 Selection of test samples
10.1.1 General
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot
10.2 Types of test samples
10.2.1 Complete structure
10.2.2 Partial structure
10.2.3 Any other structure
10.3 Preparation of test samples
10.4 Identification of test samples
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
10.5.4 Test samples for separate tests on knee locks
10.6 Worst-case alignment position of test samples
11 Responsibility for test preparation
12 Test submission document
12.1 General requirements
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
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
13 Equipment
13.1 General
13.2 Equipment for the principal tests specified in 16.2 and 16.3
13.2.1 End attachments
13.2.2 Jig (optional)
13.2.3 Test equipment
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
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
14 Accuracy
14.1 General
14.2 Accuracy of equipment
14.3 Accuracy of procedure
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
16.2 Principal static test procedure
16.2.1 Principal static proof test
16.2.2 Principal static ultimate strength test
16.3 Principal cyclic test procedure
16.3.1 General requirements
16.3.2 Test method
16.3.3 Performance requirements
16.3.4 Compliance conditions
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
17.1.4 Performance requirements
17.1.5 Compliance conditions
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
17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units
17.2.5 Separate cyclic test for ankle-foot devices and foot units
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
17.3.4 Test method
17.3.5 Performance requirement
17.3.6 Compliance conditions
17.4 Separate tests on knee locks
17.4.1 General
17.4.2 Purpose of tests
17.4.3 Separate static proof test for knee locks
17.4.4 Separate static ultimate strength test for knee locks
17.4.5 Separate cyclic test for knee locks
18 Test laboratory/facility log
18.1 General requirements
18.2 Specific requirements
19 Test report
19.1 General requirements
19.2 Specific requirements
19.3 Options
20 Classification and designation
20.1 General
20.2 Examples of classification and designation
21 Labelling
21.1 General
21.2 Use of mark “*)” and warning symbol
21.3 Examples of label layout
21.4 Label placement
Annex A (informative) Description of internal loads and their effects
Annex B (informative) Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests
Annex C (informative) Guidance on the application of an alternative static ultimate strength test
Annex D (normative) Guidance on the application of an additional test loading levels P6, P7 and P8
Annex E (informative) Summary of the records to be entered in the test laboratory/facility log
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
Annex G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142
Bibliography