DIN EN ISO 22523

External limb prostheses and external orthoses - Requirements and test methods

This standard specifies requirements for external prostheses and orthoses and indicates suitable procedures for verifying these requirements. The standard refers to its own informative annexes as well as to other standards and technical regulations.

• Appendix A: Upper limb orthoses - mechanical tests
• Annex B: Lower limb orthoses - mechanical tests for knee joint assemblies
• Annex C: Lower limb orthoses - flammability and toxicity of combustion products
• Standard DIN EN ISO 10328 Prosthetics - Testing of the structure of external prostheses for the lower limbs
• Standard ISO 22675 Prosthetics - Testing of ankle-foot fittings and foot units

Together with the above-mentioned standards, DIN EN ISO 22523 provides a compilation of specifications that allow individual basic requirements for medical devices to be applied to external limb prostheses and external orthoses. In Annex E, the standard refers to basic principles for the safety and performance of medical devices in accordance with Technical Rule ISO/TR 16142, the predecessor of ISO 16142-1/2.