NEN EN ISO 22675 : 2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Designations and symbols of test forces
5 Strength and related performance requirements and
   conditions of use
6 Coordinate system and test configurations
   6.1 General
   6.2 Origin and axes of the coordinate system
   6.3 Reference points
   6.4 Test force F
   6.5 Line of application of test force F
   6.6 Lines of action of resultant reference forces F[R1]
        and F[R2]
   6.7 Longitudinal axis of the foot and effective ankle
        joint centre
        6.7.1 General
        6.7.2 Longitudinal axis of the foot
        6.7.3 Effective ankle-joint centre, C[A]
7 Test loading conditions and test loading levels
   7.1 Test loading conditions
   7.2 Test loading levels
8 Values of test forces, dimensions and cycles
9 Compliance
   9.1 General
   9.2 Particular arrangements and requirements concerning
        the part required to connect an ankle-foot device or
        foot unit to the remainder of a prosthetic structure
        9.2.1 Arrangements for testing
        9.2.2 Requirements for claiming compliance
   9.3 Number of tests and test samples required to claim
        compliance with this International Standard
   9.4 Multiple use of test samples
        9.4.1 General
        9.4.2 Restriction
   9.5 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 sample
        10.2.1 Complete structure
        10.2.2 Partial structure
   10.3 Preparation of test samples
   10.4 Identification of test samples
   10.5 Alignment of test samples
   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
   12.3 Information required for tests
        12.3.1 General
        12.3.2 For all tests
        12.3.3 For the static proof test and the static ultimate
               strength test
        12.3.4 For the static ultimate strength test
        12.3.5 For the cyclic test
13 Equipment
   13.1 General
   13.2 End attachments
        13.2.1 General
        13.2.2 Proof test of end attachments
   13.3 Jig (optional)
   13.4 Test equipment
        13.4.1 Test equipment to perform static heel and
               forefoot loading
        13.4.2 Test equipment to perform cyclic loading
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
   16.1 Test loading requirements
        16.1.1 Preparation for test loading
        16.1.2 Test loading
   16.2 Static proof test
        16.2.1 Test method
        16.2.2 Performance requirement
        16.2.3 Compliance conditions
   16.3 Static ultimate strength test
        16.3.1 Test method
        16.3.2 Performance requirements
        16.3.3 Compliance conditions
   16.4 Cyclic test
        16.4.1 Test method
        16.4.2 Performance requirements
        16.4.3 Compliance conditions
17 Test laboratory/facility log
   17.1 General requirements
   17.2 Specific requirements
18 Test report
   18.1 General requirements
   18.2 Specific requirements
   18.3 Options
19 Classification and designation
   19.1 General
   19.2 Examples of classification and designation
20 Labelling
   20.1 General
   20.2 Use of mark '*)' and warning symbol
   20.3 Examples of label layout
   20.4 Label placement
Annex A (informative) Reference data for the specification
        of the test loading conditions and test loading levels
        of this International Standard
Annex B (informative) Guidance on the application of an
        alternative static ultimate strength test
Annex C (informative) Guidance on the application of an
        additional test loading level P6
Annex D (informative) Summary of the records to be entered
        in the test laboratory/facility log
Annex E (informative) Information on Technical Report
        ISO/TR 22676
Annex F (informative) Reference to the essential principles
        of safety and performance of medical devices according
        to ISO/TR 16142
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other provisions
         of EU Directives
Bibliography

Defines a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life.