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ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods >
ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods, 2016
- 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 [Go to Page]