Standards Development
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. It can also be used 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 may be appropriate.
This documents has not been updated since 2006. Since then there have been many relevant developments regarding external limb prostheses and external orthoses requiring updates regarding the requirements and test methods.
One particularly relevant development is the publication of the European Medical Device Regulation.
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