I.S. EN ISO 22675:2016

National Foreword
European foreword
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
7 Test loading conditions and test loading levels
8 Values of test forces, dimensions and cycles
9 Compliance
10 Test samples
11 Responsibility for test preparation
12 Test submission document
13 Equipment
14 Accuracy
15 Test principles
16 Test procedures
17 Test laboratory/facility log
18 Test report
19 Classification and designation
20 Labelling
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 (normative) - Application of an additional test loading
        level P6, P7, and P8
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
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC [OJ L 169] aimed to be covered

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.