DIN EN ISO 10328:2025-08
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO/DIS 10328:2025); German and English version prEN ISO 10328:2025 / Note: Date of issue 2025-07-04*Intended as replacement for DIN EN ISO 10328 (2016-12).
| Fecha edición: |
2025-08-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | Throughout this document, the term prosthesis means an externally applied device used to replace wholly, or in part, an absent limb segment. As a result of concern in the international community about the need to provide prostheses that are safe in use, and also because of an awareness that test standards would assist the development of better prostheses, a series of meetings was held under the aegis of the International Society for Prosthetics and Orthotics (ISPO). The final one was held in Philadelphia, PA, USA in 1977 at which a preliminary consensus was reached on methods of testing and the required load values. From 1979 onwards this work was continued by ISO Technical Committee 168 leading to the development of ISO 10328:1996. The test procedures may not be applicable to prostheses of mechanical characteristics different from those used in the consensus. During use, a prosthesis is subjected to a series of load actions, each varying individually with time. The test methods specified in this document use static and cyclic strength tests which typically produce compound loadings by the application of a single test force. The static tests relate to the worst loads generated in any activity. The cyclic tests relate to normal walking activities where loads occur regularly with each step. This document specifies fatigue testing of structural components. The tests specified do not provide sufficient data to predict actual service life. The evaluation of lower-limb prostheses and their components requires controlled field trials in addition to the laboratory tests specified in this document. The laboratory tests and field trials should be repeated when significant design changes are made to a load-bearing part of a prosthesis. Ideally, additional laboratory tests should be carried out to deal with function, wear and tear, new material developments, environmental influences and user activities as part of the evaluation procedure. There are no standards for such tests, so appropriate procedures will need to be determined. |
| Keywords: | Aids for the disabled|Artificial feet|Centres|Conformity|Coordinate systems|Definitions|Determination|Fine mechanics|Limbs|Longitudinal axis|Lower-limb-protheses|Medical devices|Medical sciences|Proof loading|Prosthetic devices|Specification (approval)|Specimens|Strength of materials|Strength tests|Stress|Structure|Technical aid|Test loading|Testing|Testing conditions|Testing devices|Testing set-ups |
| ICS: | 11.180.10 - Ayudas y adaptadores para el movimiento |
| CTN: |
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