SIST EN ISO 22675:2025 PDF

Overview

EN ISO 22675:2025 (identical to ISO 22675:2024) defines requirements and test methods for prosthetic ankle‑foot devices and foot units. The standard specifies both a cyclic test procedure that realistically simulates the full stance phase of walking (heel‑strike to toe‑off) and a static test procedure (proof and ultimate strength). These procedures are intended to verify mechanical performance attributes such as strength, durability and service life under standardized loading and locomotion profiles.

Key aspects include standardized formats for loading profiles (resultant vectors of vertical and anterior–posterior ground reaction forces), tibia angle (locomotion profile), coordinate systems, reference points and lines of action. EN ISO 22675:2025 supersedes the 2016 edition and was prepared by ISO/TC 168 in collaboration with CEN/TC 293.

Key Topics

• Cyclic testing: Simulates realistic stance‑phase loading to assess fatigue behavior and performance that only appears under dynamic, physiologic loading.
• Static testing: Includes a static proof test and static ultimate strength test that generate heel and forefoot forces with lines of action matching peak loading instants from cyclic tests.
• Test loading conditions: Defined by resultant ground reaction force vectors (vertical + A‑P) and tibia angle; applied in standardized test formats.
• Test Ranges (R): Locomotion profiles and loading levels specified relative to intended use (each device still free to develop its own performance response).
• Coordinate system & geometry: Origins, axes, longitudinal foot axis and effective ankle‑joint centre are specified to ensure repeatable mounting and force application.
• Compliance and scope linkage: Suitable for devices meeting strength requirements in ISO 22523:2006; devices already tested to ISO 10328:2016 for those strength clauses may not require retesting.

Applications

Who uses EN ISO 22675:2025:

• Prosthetic device manufacturers - to validate product strength, durability and service life claims during design and production.
• Independent test laboratories - to perform reproducible cyclic and static tests and issue compliance reports.
• Notified bodies and conformity assessors - as part of mechanical evaluation for regulatory submissions (supports EU MDR 2017/745 where applicable).
• R&D engineers and clinicians - to compare design concepts and understand in‑service performance under realistic gait loading.

Practical benefits:

• Provides repeatable test methods for product development, quality control and regulatory evidence.
• Targets modern ankle‑foot designs whose behavior emerges only under realistic cyclic loading.

Related Standards

• ISO 10328:2016 - Structural testing of lower‑limb prostheses (reference for some structural test conditions)
• ISO 22523:2006 - Requirements and test methods for external limb prostheses and orthoses
• ISO 8549‑1, ISO 7000 - referenced vocabulary and graphical symbols
• EU Regulation (EU) 2017/745 - EN ISO 22675:2025 includes Annex ZA describing relationship to MDR conformity requirements

Keywords: EN ISO 22675:2025, ISO 22675:2024, prosthetics testing, ankle‑foot devices, foot units, cyclic test, static strength test, durability testing, prosthetic standards, CEN.