NF EN ISO 22675

NF EN ISO 22675

December 2006
Standard Cancelled

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

ISO 22675:2006 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. In addition, ISO 22675:2006 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, 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.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2006

Number of pages

109 p.

Reference

NF EN ISO 22675

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S96-801

Print number

1 - 08/12/2006

International kinship

European kinship

EN ISO 22675:2006
Sumary
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods

ISO 22675:2006 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.

In addition, ISO 22675:2006 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, 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.

Standard replaced by (1)
NF EN ISO 22675
September 2016
Standard Current
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods

<p>IMPORTANT ? ISO 22675:2016 <i>is suitable</i> 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.</p> <p>WARNING ? ISO 22675:2016 is <i>not suitable</i> 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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p>

Table of contents
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  • Avant-propos
    vii
  • Introduction
    viii
  • 1
    Domaine d'application 1
  • 2
    Références normatives 2
  • 3
    Termes et définitions 2
  • 4
    Désignations et symboles des forces d'essai 2
  • 5
    Résistance et exigences de performance associées, conditions d'utilisation 3
  • 6
    Systèmes des coordonnées et configurations d'essai 4
  • 6.1
    Généralités 4
  • 6.2
    Origines et axes des repères orthonormés 4
  • 6.3
    Points de référence 5
  • 6.4
    Force d'essai F 6
  • 6.5
    Ligne d'application de la force d'essai F 6
  • 6.6
    Lignes d'action des forces de référence résultantes, FR, et FR2 6
  • 6.7
    Axe longitudinal du pied, centre réel de l'articulation de la cheville 6
  • 7
    Conditions de mise en contrainte et niveaux de contrainte d'essai 8
  • 7.1
    Conditions de mise en contrainte d'essai 8
  • 7.2
    Niveaux de contrainte d'essai 9
  • 8
    Valeurs des forces d'essai, des dimensions et des cycles 10
  • 9 Conformité
    18
  • 9.1
    Généralités 18
  • 9.2
    Dispositifs et exigences particuliers relatifs à la partie nécessaire pour relier un ensemble cheville-pied ou unité de pied soumis(e) à essai au reste d'une structure prothétique 19
  • 9.3
    Nombre d'essais et d'échantillons d'essai requis pour une déclaration de conformité à la présente Norme internationale 19
  • 9.4
    Usage multiple des échantillons d'essai 20
  • 9.5
    Essai à des niveaux de contrainte d'essai spécifiques non spécifiés dans la présente norme 20
  • 10
    Éprouvettes 21
  • 10.1
    Sélection des éprouvettes 21
  • 10.2
    Types d'éprouvettes 22
  • 10.3
    Préparation des éprouvettes 23
  • 10.4
    Identification des éprouvettes 23
  • 10.5
    Alignement des éprouvettes 23
  • 10.6
    Position d'alignement la plus défavorable des échantillons d'essai 23
  • 11
    Responsabilités pour la préparation de l'essai 26
  • 12
    Bon de commande pour l'essai 27
  • 12.1
    Exigences générales 27
  • 12.2
    Informations requises, relatives aux échantillons d'essai 28
  • 12.3
    Informations requises, relatives aux essais 28
  • 13 Équipement
    29
  • 13.1 Généralités
    29
  • 13.2
    Pièces de liaison 29
  • 13.3
    Dispositif de serrage (facultatif) 32
  • 13.4
    Équipement d'essai 32
  • 14
    Exactitude 41
  • 14.1 Généralités
    41
  • 14.2
    Exactitude de l'équipement 41
  • 14.3
    Exactitude du mode opératoire 42
  • 15
    Principes d'essai 42
  • 15.1 Généralités
    42
  • 15.2
    Mode opératoire de l'essai statique 43
  • 15.3
    Mode opératoire de l'essai cyclique 43
  • 16
    Modes opératoires d'essai 43
  • 16.1
    Exigences de mise en contrainte d'essai 43
  • 16.2
    Essai statique de charge 47
  • 16.3
    Essai statique de résistance à la rupture 51
  • 16.4
    Essai cyclique 57
  • 17
    Journal de laboratoire/d'organisme d'essai 63
  • 17.3
    Exigences générales 63
  • 17.4
    Exigences spécifiques 63
  • 18
    Rapport d'essai 63
  • 18.3
    Exigences générales 63
  • 18.4
    Exigences spécifiques 64
  • 18.5 Options
    64
  • 19
    Classification et désignation 64
  • 19.1 Généralités
    64
  • 19.2
    Exemples de classification et de désignation 64
  • 20 Étiquetage
    65
  • 20.1
    Généralités 65
  • 20.2
    Utilisation du signe "*)" et symbole d'avertissement 66
  • 20.3
    Exemples de mise en forme de l'étiquette 66
  • 20.4
    Emplacement de l'étiquette 67
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