ISO 22675:2016
Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods
IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to this International Standard.
WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.
ISO 22675:2016 primarily specifies 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.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, ISO 22675:2016 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.
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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 FR1 and FR2
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, CA
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 conditions
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 (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[[1]]
Annex F (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142
Bibliography
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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 FR1 and FR2
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, CA
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 conditions
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 (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[[1]]
Annex F (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142
Bibliography