ISO 22523:2006 (International Organisation for Standards)

• Ensures the ankle device meets mechanical strength, durability, and fatigue testing requirements for external orthoses. Directly informs the load-bearing specifications and cyclic stress testing needed for adjustable support stages, preventing failure during gait.

ISO 10993-18:2020 (International Organisation for Standards)

• Guides material selection to ensure skin-contact components are non-toxic, hypoallergenic, and free of harmful residues.

ISO 14971:2019 (International Organisation for Standards)

• Defines the framework for identifying hazards (over-compression, instability during partial support, mechanical failure) and implementing risk control measures.

ASTM  F3109-22 (FDA Standards)

• Relevant for validating any force-sensing system used to monitor patient loading. Ensures accuracy in force/torque measurements.

IEC  80601-2-78 Edition 1.0 2019-07 (FDA Standards)

• This standard provides safety/performance benchmarks for rehab/assistive devices and classifies external ankle braces as “Class 1 (low risk)” devices, guiding the design process.