NEN EN ISO 10328 : 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 centerlines
        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 L[A] and L[K]
        6.8.4 Distance L[BT]
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 (informative) Guidance on the application of an
        additional test loading level P6
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

Defines procedures for static and cyclic strength tests on lower-limb prostheses which typically produce compound loadings by the application of a single test force.