This document specifies requirements and test methods for external limb prostheses and external orthoses,
including the following classifications from ISO 9999:
06 03 to 06 15 Orthoses
06 18 to 06 24 Limb prostheses
This document 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 guidance in the design and test of custom build orthosis and prosthesis.
NOTE The use of quality systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.
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