NF EN ISO 22675

NF EN ISO 22675

September 2016
Standard Current

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods

IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). 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 10328:2006, need not be retested to this International Standard. WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees. ISO 22675:2016 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are 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, ISO 22675:2016 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 2) 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. The loading conditions addressed in the third paragraph 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 International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2016

Number of pages

113 p.

Reference

NF EN ISO 22675

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S96-801

Print number

1

International kinship

European kinship

EN ISO 22675:2016
Sumary
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods

IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). 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 10328:2006, need not be retested to this International Standard.

WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.

ISO 22675:2016 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are 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, ISO 22675:2016 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 2) 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.

The loading conditions addressed in the third paragraph 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 International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.

Replaced standards (1)
NF EN ISO 22675
December 2006
Standard Cancelled
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods

Le présent document spécifie un mode opératoire d'essais cycliques portant sur les ensembles cheville-pied et les unités de pied des prothèses externes pour membres inférieurs. Ce mode opératoire se distingue par la possibilité de modéliser, de manière réaliste, les conditions de mise en contrainte pendant la phase complète d'appui lors de la marche (depuis l'attaque au talon jusqu'au décollement des orteils), qui sont pertinentes pour la vérification des exigences de performances telles que la résistance, la durabilité et la durée de vie de l'appareil. Il spécifie également un mode opératoire d'essai statique portant sur les ensembles cheville-pied et unités de pied prothétiques, qui comprend un essai statique de charge et un essai statique de résistance à la rupture. L'essai se distingue, entre autres, par la possibilité de générer des forces du talon et de l'avant du pied au niveau de lignes d'action comparables à celles développées au moment où s'exercent les contraintes maximales au niveau du talon et de l'avant du pied lors de l'essai cyclique. Il n'a pas pour objectif de proposer des critères permettant de choisir un ensemble cheville-pied ou une unité de pied prothétique spécifique lors de la prescription d'une prothèse de membre inférieur.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Désignations et symboles des forces d'essai
  • 5 Résistance et exigences de performances associées, conditions d'utilisation
  • 6 Système de coordonnées et configurations d'essai
  • 7 Conditions de mise en contrainte d'essai et niveaux de contrainte d'essai
  • 8 Valeurs des forces d'essai, des dimensions et des cycles
  • 9 Conformité
  • 10 Échantillons d'essai
  • 11 Responsabilités pour la préparation de l'essai
  • 12 Bon de commande de l'essai
  • 13 Équipement
  • 14 Exactitude
  • 15 Principes d'essai
  • 16 Modes opératoires d'essai
  • 17 Journal de laboratoire/d'organisme d'essai
  • 18 Rapport d'essai
  • 19 Classification et désignation
  • 20 Étiquetage
  • Annexe C(normative) Application of an additional test loading level P6, P7, and P8
  • Annexe A(informative) Reference data for the specification of the test loading conditions and test loading levels of this International Standard
  • Annexe B(informative) Guidance on the application of an alternative static ultimate strength test
  • Annexe D(informative) Summary of the records to be entered in the test laboratory/ facility log
  • Annexe E(informative) Information on Technical Report ISO/TR 22676[1]
  • Annexe F(informative) Reference to the essential principles of safety and performance of medical devices according to ISO/TR
    16142
  • Annexe ZA(informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 93/42/CEE [JO L 169]
  • Bibliographie
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