Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Designations and symbols of test forces <br>&nbsp;&nbsp;&nbsp;and moments<br>5 Strength and related performance <br>&nbsp;&nbsp;&nbsp;requirements and conditions of use<br>6 Coordinate systems and test configurations<br>7 Test loading conditions and test loading levels<br>8 Values of test loads, dimensions and cycles<br>9 Compliance<br>10 Test samples<br>11 Responsibility for test preparation<br>12 Test submission document<br>13 Equipment<br>14 Accuracy<br>15 Test principles<br>16 Test procedures - Principal structural tests<br>17 Test procedures - Separate structural tests<br>18 Test laboratory/facility log<br>19 Test report<br>20 Classification and designation<br>21 Labelling<br>Annex A (informative) - Description of internal loads and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;their effects<br>Annex B (informative) - Reference data for the specification <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of test loading conditions and test loading levels of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;principal cyclic tests<br>Annex C (informative) - Guidance on the application <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of an alternative static ultimate strength test<br>Annex D (normative) - Guidance on the application <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of an additional test loading levels P6, P7 and P8<br>Annex E (informative) - Summary of the records to <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;be entered in the test laboratory/facility log<br>Annex F (informative) - Background information on <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the loading profiles generated by test equipment <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;according to 13.4.1.2 for separate cyclic tests <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for ankle-foot devices and foot units <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;according to 17.2.5.1<br>Annex G (informative) - Reference to the essential principles <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of safety and performance of medical devices <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;according to ISO/TR 16142<br>Annex ZA (informative) - Relationship between this <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the Essential Requirements <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of EU Directive 93/42/EEC [OJ L 169] aimed <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;to be covered<br>Bibliography

Abstract

Describes procedures for static and cyclic strength tests on lower-limb prostheses where, with one exception, compound loadings are produced by the application of a single test force.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/168
Supersedes	BS ISO 10328-2 : 1996 BS ISO 10328-1 : 1996 BS ISO 10328-8 : 1996 BS ISO 10328-5 : 1996 BS ISO 10328-3 : 1996 BS ISO 10328-6 : 1996 BS ISO 10328-7 : 1996 BS ISO 10328-4 : 1996 03/317879 DC : DRAFT OCT 2003