BS EN ISO 22675:2016 – TC:2020 Edition
$280.87
Tracked Changes. Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 216 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 114 | European foreword |
| 115 | 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 Table ZA.1 — Correspondence between this European standard and Annex I of Directive 93/42/EEC [OJ L 169] |
| 120 | Foreword |
| 121 | Introduction |
| 123 | 1 Scope 2 Normative references |
| 124 | 3 Terms and definitions 4 Designations and symbols of test forces |
| 125 | 5 Strength and related performance requirements and conditions of use |
| 126 | 6 Coordinate system and test configurations 6.1 General 6.2 Origin and axes of the coordinate system |
| 127 | 6.3 Reference points |
| 128 | 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 |
| 129 | 6.7.3 Effective ankle-joint centre, CA |
| 130 | 7 Test loading conditions and test loading levels 7.1 Test loading conditions 7.2 Test loading levels |
| 131 | 8 Values of test forces, dimensions and cycles |
| 138 | 9 Compliance 9.1 General |
| 139 | 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 |
| 140 | 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 |
| 141 | 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 |
| 142 | 10.2 Types of test sample 10.2.1 Complete structure 10.2.2 Partial structure 10.3 Preparation of test samples |
| 143 | 10.4 Identification of test samples 10.5 Alignment of test samples 10.6 Worst-case alignment position of test samples |
| 145 | 11 Responsibility for test preparation |
| 146 | 12 Test submission document 12.1 General requirements 12.2 Information required for test samples |
| 147 | 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 |
| 148 | 13 Equipment 13.1 General 13.2 End attachments 13.2.1 General 13.2.2 Proof test of end attachments |
| 150 | 13.3 Jig (optional) |
| 151 | 13.4 Test equipment 13.4.1 Test equipment to perform static heel and forefoot loading |
| 152 | 13.4.2 Test equipment to perform cyclic loading |
| 159 | 14 Accuracy 14.1 General 14.2 Accuracy of equipment 14.3 Accuracy of procedure |
| 160 | 15 Test principles 15.1 General |
| 161 | 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 |
| 165 | 16.1.2 Test loading conditions 16.2 Static proof test 16.2.1 Test method |
| 167 | 16.2.2 Performance requirement 16.2.3 Compliance conditions |
| 169 | 16.3 Static ultimate strength test 16.3.1 Test method |
| 172 | 16.3.2 Performance requirements 16.3.3 Compliance conditions |
| 173 | 16.4 Cyclic test 16.4.1 Test method |
| 176 | 16.4.2 Performance requirements |
| 177 | 16.4.3 Compliance conditions |
| 179 | 17 Test laboratory/facility log 17.1 General requirements 17.2 Specific requirements 18 Test report 18.1 General requirements |
| 180 | 18.2 Specific requirements 18.3 Options 19 Classification and designation 19.1 General 19.2 Examples of classification and designation |
| 181 | 20 Labelling 20.1 General |
| 182 | 20.2 Use of mark “*)” and warning symbol 20.3 Examples of label layout |
| 183 | 20.4 Label placement |
| 184 | Annex A (informative) Reference data for the specification of the test loading conditions and test loading levels of this International Standard |
| 192 | Annex B (informative) Guidance on the application of an alternative static ultimate strength test |
| 193 | Annex C (normative) Application of an additional test loading level P6, P7, and P8 |
| 195 | Annex D (informative) Summary of the records to be entered in the test laboratory/facility log |
| 201 | Annex E (informative) Information on Technical Report ISO/TR 22676[[1]] |
| 212 | Annex F (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142 |
| 213 | Bibliography |
