NF EN ISO 10328

NF EN ISO 10328

October 2016
Standard Current

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods

IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures 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 ISO 22675:2016. WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees. ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2016

Number of pages

152 p.

Reference

NF EN ISO 10328

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S96-802

Print number

1

International kinship

European kinship

EN ISO 10328:2016
Sumary
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods

IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures 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 ISO 22675:2016.

WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.

ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.

Replaced standards (1)
NF EN ISO 10328
December 2006
Standard Cancelled
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods

Le présent document spécifie des modes opératoires d'essais de résistance statiques et cycliques des prothèses des membres inférieurs qui produisent typiquement, à une exception près, des contraintes combinées par l'application d'une force d'essai unique. Les essais décrits dans le présent document s'appliquent aux prothèses utilisées en cas de désarticulation de la cheville, aux prothèses transtibiales (pour amputation au niveau de la jambe, sous le niveau du genou), aux prothèses utilisées en cas de désarticulation du genou et aux prothèses transfémorales (au niveau de la cuisse, au-dessus du genou), aux prothèses utilisées en cas de désarticulation de la partie (inférieure) distale de la hanche et aux prothèses pour hémipelvectomie. Le présent document ne peut pas servir de guide pour choisir une prothèse/structure prothétique lors de la prescription d'une prothèse de membre inférieur.

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Désignations et symboles des forces d'essai et des moments
  • 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 contraintes d'essai, dimensions et cycles
  • 9 Conformité
  • 10 Échantillons d'essai
  • 11 Responsabilités relatives à la préparation d'essai
  • 12 Bon de commande de l'essai
  • 13 Équipement
  • 14 Exactitude
  • 15 Principes d'essai
  • 16 Modes opératoires d'essai - Essais principaux de structure
  • 17 Modes opératoires d'essai - Essais de structure séparés
  • 18 Journal de laboratoire/d'organisme d'essai
  • 19 Rapport d'essai
  • 20 Classification et désignation
  • 21 Étiquetage
  • Annexe A Description of internal loads and their effects
  • Annexe B Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests
  • Annexe C Guidance on the application of an alternative static ultimate strength test
  • Annexe D Guidance on the application of an additional test loading levels P6, P7 and P8
  • Annexe E Summary of the records to be entered in the test laboratory/facility log
  • Annexe F Background information on the loading profiles generated by test equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot units according to 17.2.5.1
  • Annexe G Reference to the essential principles of safety and performance of medical devices according to ISO/TR
    16142
  • Bibliographie
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