This International Standard 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 International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.
NOTE 1 – It is intended to cover orthopaedic footwear (classification 06 33) in the future.
NOTE 2 – The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 may be appropriate.