scope:

This document specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 - 06 15 Orthoses 06 18 - 06 27 Limb prostheses It 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. This document is also applicable as a guide in the design and test of custom build orthosis and prosthesis. NOTE - The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.