I.S. EN ISO 22675:2016
Current
The latest, up-to-date edition.
PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016)
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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