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