BS EN ISO 10328:2016 – TC:2020 Edition
$280.87
Tracked Changes. Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 318 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 166 | European foreword |
| 167 | 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] |
| 173 | Foreword |
| 174 | Introduction |
| 175 | 1 Scope 2 Normative references |
| 176 | 3 Terms and definitions 4 Designations and symbols of test forces and moments |
| 177 | 5 Strength and related performance requirements and conditions of use |
| 179 | 6 Coordinate systems and test configurations 6.1 General 6.2 Axes of coordinate systems 6.3 Reference planes 6.3.1 General 6.3.2 Top reference plane, T 6.3.3 Knee reference plane, K |
| 180 | 6.3.4 Ankle reference plane, A 6.3.5 Bottom reference plane, B |
| 181 | 6.4 Reference points |
| 182 | 6.5 Test force 6.6 Load line 6.7 Longitudinal axis of the foot and effective joint centres and centrelines 6.7.1 General 6.7.2 Longitudinal axis of the foot 6.7.3 Effective ankle-joint centre |
| 184 | 6.7.4 Effective ankle-joint centreline 6.7.5 Effective knee-joint centreline |
| 185 | 6.7.6 Effective knee-joint centre 6.8 Reference distances 6.8.1 Offsets 6.8.2 Combined offsets 6.8.3 Effective lever arms LA and LK 6.8.4 Distance LBT 7 Test loading conditions and test loading levels 7.1 Test loading conditions 7.1.1 General |
| 186 | 7.1.2 Test loading conditions of principal structural tests 7.1.3 Test loading conditions of separate structural tests 7.2 Test loading levels |
| 187 | 8 Values of test loads, dimensions and cycles |
| 194 | 9 Compliance 9.1 General |
| 195 | 9.2 Selection of tests required to claim compliance with this International Standard 9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices or foot units, required to claim compliance with this International Standard 9.3.1 General 9.3.2 Particular arrangements concerning the ankle-foot device or foot unit 9.3.3 Particular arrangements and requirements concerning the part required to connect the ankle-foot device or foot unit to the remainder of the prosthetic structure |
| 196 | 9.4 Number of tests and test samples required to claim compliance with this International Standard 9.5 Multiple use of test samples 9.5.1 General 9.5.2 Restriction |
| 197 | 9.6 Testing at particular test loading levels not specified in this International Standard |
| 199 | 10 Test samples 10.1 Selection of test samples 10.1.1 General |
| 200 | 10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot |
| 201 | 10.2 Types of test samples 10.2.1 Complete structure |
| 203 | 10.2.2 Partial structure 10.2.3 Any other structure 10.3 Preparation of test samples |
| 204 | 10.4 Identification of test samples |
| 205 | 10.5 Alignment of test samples 10.5.1 Test samples for principal tests and separate tests on knee locks 10.5.2 Test samples for separate tests on ankle-foot devices and foot units 10.5.3 Test samples for separate static ultimate strength tests in maximum knee flexion for knee joints and associated parts |
| 206 | 10.5.4 Test samples for separate tests on knee locks 10.6 Worst-case alignment position of test samples |
| 207 | 11 Responsibility for test preparation |
| 208 | 12 Test submission document 12.1 General requirements |
| 209 | 12.2 Information required for test samples 12.2.1 All test samples 12.2.2 Test samples for tests on ankle-foot devices and foot units 12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints and associated parts 12.3 Information required for tests 12.3.1 General 12.3.2 For all tests |
| 210 | 12.3.3 For static tests in torsion and on ankle-foot devices and foot units 12.3.4 For static ultimate strength tests 12.3.5 For cyclic tests 12.3.6 For tests in torsion 12.3.7 For tests on ankle-foot devices and foot units |
| 211 | 13 Equipment 13.1 General 13.2 Equipment for the principal tests specified in 16.2 and 16.3 13.2.1 End attachments |
| 213 | 13.2.2 Jig (optional) |
| 214 | 13.2.3 Test equipment |
| 216 | 13.3 Equipment for the separate static test in torsion specified in 17.1 13.3.1 Test equipment 13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 13.4.1 Test equipment |
| 220 | 13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3 13.5.1 Extension pieces 13.5.2 Test equipment to perform static compression loading – (Compression testing machine or other equipment) 13.6 Equipment for the separate tests on knee locks specified in 17.4 13.6.1 End attachments 13.6.2 Jig (optional) 13.6.3 Test equipment |
| 221 | 14 Accuracy 14.1 General 14.2 Accuracy of equipment 14.3 Accuracy of procedure |
| 222 | 15 Test principles 15.1 General 15.2 Static test procedure 15.3 Cyclic test procedure 16 Test procedures – Principal structural tests 16.1 Test loading requirements 16.1.1 Preparation for test loading 16.1.2 Application of test loading |
| 224 | 16.2 Principal static test procedure 16.2.1 Principal static proof test |
| 229 | 16.2.2 Principal static ultimate strength test |
| 233 | 16.3 Principal cyclic test procedure 16.3.1 General requirements 16.3.2 Test method |
| 237 | 16.3.3 Performance requirements |
| 238 | 16.3.4 Compliance conditions |
| 242 | 17 Test procedures — Separate structural tests 17.1 Separate static test in torsion 17.1.1 General 17.1.2 Purpose of test 17.1.3 Test method |
| 244 | 17.1.4 Performance requirements 17.1.5 Compliance conditions |
| 246 | 17.2 Separate tests on ankle-foot devices and foot units 17.2.1 General 17.2.2 Purpose of tests 17.2.3 Separate static proof test for ankle-foot devices and foot units |
| 250 | 17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units |
| 255 | 17.2.5 Separate cyclic test for ankle-foot devices and foot units |
| 260 | 17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts 17.3.1 General 17.3.2 Purpose of test 17.3.3 Applicability of the test to specific test samples |
| 261 | 17.3.4 Test method |
| 262 | 17.3.5 Performance requirement 17.3.6 Compliance conditions |
| 263 | 17.4 Separate tests on knee locks 17.4.1 General |
| 264 | 17.4.2 Purpose of tests 17.4.3 Separate static proof test for knee locks |
| 268 | 17.4.4 Separate static ultimate strength test for knee locks |
| 270 | 17.4.5 Separate cyclic test for knee locks |
| 279 | 18 Test laboratory/facility log 18.1 General requirements 18.2 Specific requirements 19 Test report 19.1 General requirements |
| 280 | 19.2 Specific requirements 19.3 Options 20 Classification and designation 20.1 General 20.2 Examples of classification and designation |
| 281 | 21 Labelling 21.1 General |
| 282 | 21.2 Use of mark “*)” and warning symbol 21.3 Examples of label layout 21.4 Label placement |
| 284 | Annex A (informative) Description of internal loads and their effects |
| 288 | Annex B (informative) Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests |
| 292 | Annex C (informative) Guidance on the application of an alternative static ultimate strength test |
| 293 | Annex D (normative) Guidance on the application of an additional test loading levels P6, P7 and P8 |
| 296 | Annex E (informative) Summary of the records to be entered in the test laboratory/facility log |
| 311 | 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 |
| 313 | Annex G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR 16142 |
| 314 | Bibliography |
