Testing Standards

Various ISO quality standards exist for the structural testing of prosthetic components in laboratory settings (see table 43). These standards focus on the durability of the components.

Table 43: ISO standards for structural testing for Prostheses.

ISO 10328:2016 Specifies procedures for static and cyclic strength tests on lower- limb prostheses which typically produce compound loadings by the application of a single test force. Suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006. i
ISO 22523:2006 Covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. Specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 – 06 15 Orthoses and 06 18 – 06 27 Limb prostheses. ii

iISO 10328:2016 – Prosthetics --- Structural testing of lower-limb prostheses — Requirements and test methods, https://www.iso.org/standard/70205.html. ↩︎

iiISO 22523:2006 – External limb prostheses and external orthoses — Requirements and test methods, https:// www.iso.org/standard/37546.html. ↩︎

The following are limitations to the current ISO system: