NF EN ISO 22675
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.
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.
<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>
- Avant-proposvii
- Introductionviii
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1Domaine d'application 1
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2Références normatives 2
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3Termes et définitions 2
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4Désignations et symboles des forces d'essai 2
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5Résistance et exigences de performance associées, conditions d'utilisation 3
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6Systèmes des coordonnées et configurations d'essai 4
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6.1Généralités 4
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6.2Origines et axes des repères orthonormés 4
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6.3Points de référence 5
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6.4Force d'essai F 6
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6.5Ligne d'application de la force d'essai F 6
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6.6Lignes d'action des forces de référence résultantes, FR, et FR2 6
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6.7Axe longitudinal du pied, centre réel de l'articulation de la cheville 6
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7Conditions de mise en contrainte et niveaux de contrainte d'essai 8
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7.1Conditions de mise en contrainte d'essai 8
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7.2Niveaux de contrainte d'essai 9
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8Valeurs des forces d'essai, des dimensions et des cycles 10
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9 Conformité18
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9.1Généralités 18
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9.2Dispositifs 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
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9.3Nombre d'essais et d'échantillons d'essai requis pour une déclaration de conformité à la présente Norme internationale 19
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9.4Usage multiple des échantillons d'essai 20
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9.5Essai à des niveaux de contrainte d'essai spécifiques non spécifiés dans la présente norme 20
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10Éprouvettes 21
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10.1Sélection des éprouvettes 21
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10.2Types d'éprouvettes 22
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10.3Préparation des éprouvettes 23
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10.4Identification des éprouvettes 23
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10.5Alignement des éprouvettes 23
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10.6Position d'alignement la plus défavorable des échantillons d'essai 23
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11Responsabilités pour la préparation de l'essai 26
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12Bon de commande pour l'essai 27
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12.1Exigences générales 27
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12.2Informations requises, relatives aux échantillons d'essai 28
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12.3Informations requises, relatives aux essais 28
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13 Équipement29
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13.1 Généralités29
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13.2Pièces de liaison 29
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13.3Dispositif de serrage (facultatif) 32
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13.4Équipement d'essai 32
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14Exactitude 41
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14.1 Généralités41
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14.2Exactitude de l'équipement 41
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14.3Exactitude du mode opératoire 42
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15Principes d'essai 42
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15.1 Généralités42
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15.2Mode opératoire de l'essai statique 43
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15.3Mode opératoire de l'essai cyclique 43
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16Modes opératoires d'essai 43
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16.1Exigences de mise en contrainte d'essai 43
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16.2Essai statique de charge 47
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16.3Essai statique de résistance à la rupture 51
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16.4Essai cyclique 57
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17Journal de laboratoire/d'organisme d'essai 63
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17.3Exigences générales 63
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17.4Exigences spécifiques 63
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18Rapport d'essai 63
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18.3Exigences générales 63
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18.4Exigences spécifiques 64
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18.5 Options64
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19Classification et désignation 64
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19.1 Généralités64
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19.2Exemples de classification et de désignation 64
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20 Étiquetage65
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20.1Généralités 65
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20.2Utilisation du signe "*)" et symbole d'avertissement 66
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20.3Exemples de mise en forme de l'étiquette 66
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20.4Emplacement de l'étiquette 67
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