Hivatkozási szám

MSZ EN ISO 22675:2025

Dokumentumazonosító

186639

Cím

Protézisek. Boka-láb eszközök és lábegységek vizsgálata. Követelmények és vizsgálati módszerek (ISO 22675:2024)

Angol cím

Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods (ISO 22675:2024)

Alkalmazási terület

This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life. This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading. In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test. These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle. The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test. This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load. This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2016, need not be retested to this document. NOTE The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.

ICS

11.040.40 Sebészeti implantátumok, protézisek és ortézisek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2025-11-01

Forrás

idt EN ISO 22675:2025; idt ISO 22675:2024

Előd

MSZ EN ISO 22675:2016

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

2017/745/EU (MDV17)

A szabvány

kapható formátuma

Papír ,
PDF (letöltés) (a fájl mérete: 3369333) ,

oldalszáma

7 oldal; D kategória

ára

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