I.S. EN ISO 10328:2016

National Foreword
European foreword
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
7 Test loading conditions and test loading levels
8 Values of test loads, 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 - Principal structural tests
17 Test procedures - Separate structural tests
18 Test laboratory/facility log
19 Test report
20 Classification and designation
21 Labelling
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
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
Bibliography