ISO 22675:2024

Overview

ISO 22675:2024 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods defines standardized mechanical test procedures to assess the strength, durability and service life of ankle‑foot prosthetic devices and foot units. The standard focuses on realistic simulation of the complete stance phase of walking (heel strike to toe-off) using both cyclic and static test methods. Test loading profiles are determined by the resultant ground reaction force vector and the tibia angle, and are applied in standardized formats to each submitted sample.

Key topics and technical requirements

• Cyclic test procedure: A repeatable, time-varying loading regime that simulates heel-to-toe loading during walking to evaluate durability and endurance under realistic conditions.
• Static tests: Includes the static proof test and the static ultimate strength test, which generate heel and forefoot forces with lines of action matching peak loading instants in the cyclic test.
• Test Ranges (R): Locomotion profiles and specified test ranges tied to intended use (e.g., activity level or user mass) to ensure representative loading.
• Coordinate system & test configuration: Defined origins, axes, reference points, and lines of action for reproducible loading and alignment.
• Sample preparation and alignment: Procedures for selecting, preparing and aligning complete or partial structures, including worst‑case alignment positions.
• Equipment, accuracy and jigs: Requirements for end attachments, test rigs, cyclic and static actuators, and measurement accuracy.
• Compliance and documentation: Test submission documents, number of samples, compliance criteria and laboratory logs.
• Torsion test option: Separate static torsion assessment for relevant devices.

Practical applications

• Verifying mechanical performance of new ankle‑foot devices and foot units during design validation and pre‑market testing.
• Supporting product claims for durability, service life and structural strength.
• Guiding selection of materials and geometries to meet intended activity levels.
• Enabling reproducible lab testing for quality control and comparative evaluations.

Who should use this standard

• Prosthetic device manufacturers and R&D teams validating ankle‑foot products.
• Independent test laboratories performing mechanical characterization and certification testing.
• Regulatory bodies and conformity assessors reviewing mechanical safety and performance.
• Clinical engineers and prosthetists interpreting test evidence for device selection and risk assessment.

Related standards

• ISO 22523:2006 (strength requirements for prosthetic components) - ISO 22675 is suitable for devices meeting the strength class in section 4.4 of ISO 22523.
• ISO 10328:2016 (structural testing of lower‑limb prostheses) - devices previously tested to ISO 10328 may not require retesting to ISO 22675 for the same strength requirements.

Keywords: ISO 22675:2024, prosthetics testing, ankle-foot devices, foot units, cyclic testing, static proof test, static ultimate strength, durability testing, prosthetic standards.