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Standards Development
This document describes the procedure for structural testing of distal interface components from prosthetic sockets and clarifies available information from ISO 10328:2016 therefore. It includes test description for distal socket regions with connections, specifically designed for manufacturing techniques like 3D-printing.
This document does not specify:
- the holistic, full system testing of prosthetic sockets
- the influence of gait or biomechanical analysis on socket design
- the influence of fitting procedures from prosthetists on socket design
The distal end of a prosthetic socket is a critical interface for load transfer and alignment in lower-limb prostheses. ISO 10328 and ISO 22675 are the mainly used standards for durability testing in field of prosthetics lower extremity. Beside the very detailed description of testing procedures for functional and structural components, the description to test distal interface components of prosthetic sockets is limited. This opens room for interpretation and currently published test reports are not based on a standard and therefore not comparable at all. Prosthetic sockets are manually, and custom fabricated from fibre reinforced plastics. With the rise of new production technologies like 3D-print and the changed requests from regulatory or reimbursement organizations, the need for standardized testing procedures comes up. While the ISO/TC WG 168 WG 3 works in parallel on a holistic, full scope testing procedure for highly individual prosthetic sockets, this document describes the specific testing process for the distal region of prosthetic sockets. This part of the socket builds the connection to functional components and shows the highest risk for amputees if it fails. Main goal of the new testing procedure is the avoidance or mitigation of sudden failures and following injuries for the amputees. The aim of the standard is to propose a repeatable test method of distal socket components using already existing equipment and based on known test set-up from ISO10328. (Please use this field or attach an annex)
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