ISO 22675-2024 PDF

Full title and description

ISO 22675:2024 — Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods. This international standard specifies cyclic and static mechanical test procedures, standardized loading and locomotion profiles, and test ranges for the verification of strength, durability and service life of external lower-limb prosthetic ankle‑foot devices and foot units.

Abstract

ISO 22675:2024 primarily defines a cyclic test procedure that simulates the full stance phase of walking (heel strike to toe‑off) and a static test procedure (proof and ultimate strength) for ankle‑foot devices and foot units. Tests use standardized resultant ground‑reaction loading profiles and tibia‑angle locomotion profiles; the document introduces Test Ranges (R) tied to intended use and is intended to support assessment of strength, durability and service life.

General information

• Status: Published.
• Publication date: 5 December 2024 (third edition, published 2024‑12).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics; prepared by ISO/TC 168 (Prosthetics and orthotics).
• Edition / version: Edition 3 (2024).
• Number of pages: 91 pages (official ISO PDF pagination; some national adopters report slightly different pagination in their endorsed documents).

Scope

This standard applies to external lower‑limb prosthetic ankle‑foot devices and foot units and specifies mechanical test procedures to verify structural performance (strength, durability and expected service life). It defines cyclic and static loading formats based on resultant vertical and anterior‑posterior ground reaction forces and on tibia angle locomotion profiles, and it establishes Test Ranges (R) and specific loading levels for different intended uses. ISO 22675:2024 is intended for use in type testing and design verification; devices already demonstrated compliant to the strength requirements of ISO 22523 via ISO 10328 type tests need not be retested solely because of this new document.

Key topics and requirements

• Standardized cyclic test procedure simulating the complete stance phase of gait (heel strike to toe‑off).
• Static test procedure including a static proof test and static ultimate strength test, producing heel and forefoot force lines of action comparable to cyclic maxima.
• Definition of Test Ranges (R) and specified locomotion profiles tied to intended use categories.
• Standardized formats for loading and locomotion profiles (resultant vector of vertical and A‑P ground reaction forces; tibia angle).
• Compatibility and normative relationships with existing strength/conformity requirements (references to ISO 22523 requirements and to ISO 10328 test methods).

Typical use and users

Used by prosthetic component manufacturers, R&D and test laboratories, conformity assessment and certification bodies, regulatory authorities, and technical committees drafting product approvals or procurement specifications. Clinical engineers and designers may consult the standard to understand mechanical verification expectations, but selection of an individual device for a patient remains a clinical decision beyond the scope of this test standard.

Related standards

Key associated documents include ISO 22523 (requirements for lower‑limb prosthetic components), ISO 10328 (structural testing of lower‑limb prostheses), and ISO/TR 22676 (guidance on application of the loading conditions and test equipment design). The standard was prepared by ISO/TC 168 and supersedes ISO 22675:2016 (second edition). European and national adopters may publish EN/IDT versions for regional use.

Keywords

prosthetics, ankle‑foot device, foot unit, mechanical testing, cyclic test, static test, loading profile, tibia angle, test ranges, durability, strength, ISO 22675.

FAQ

Q: What is this standard?

A: ISO 22675:2024 is an international standard that specifies mechanical test methods (cyclic and static) and requirements for testing ankle‑foot devices and foot units used in external lower‑limb prostheses.

Q: What does it cover?

A: It covers the definition of standardized loading and locomotion profiles, cyclic and static test procedures, Test Ranges related to intended device use, and guidance for verifying strength, durability and service life. It is focused on type/design testing rather than clinical prescription.

Q: Who typically uses it?

A: Manufacturers, test laboratories, conformity assessment bodies, regulators and standards committees, plus designers and clinical engineers who need to verify mechanical performance of prosthetic ankle‑foot components.

Q: Is it current or superseded?

A: Current — ISO 22675:2024 (third edition) was published in December 2024 and supersedes ISO 22675:2016 (second edition). Users of the earlier edition should consult the 2024 edition for updated test ranges and procedures.

Q: Is it part of a series?

A: Yes — it sits within the family of prosthetics and orthotics standards maintained by ISO/TC 168 and is normatively related to ISO 22523 and ISO 10328; complementary guidance appears in ISO/TR 22676. Regional adoption as EN ISO documents may follow.

Q: What are the key keywords?

A: prosthetics; ankle‑foot; foot unit; cyclic testing; static testing; loading profile; tibia angle; test ranges; durability; strength.