Norm

NEN-EN-ISO 22675:2016 en

Prothesen - Beproeving van de enkel-voethulpstukken en voetunits - Eisen en beproevingsmethoden

179,33

Over deze norm

Status Definitief
Aantal pagina's 91
Commissie Rolstoelen
Gepubliceerd op 01-06-2016
Taal Engels
NEN-EN-ISO 22675 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 - This International Standard 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. This International Standard 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, this International Standard 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. According to the concept of the tests of this International Standard, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.

Details

ICS-code 11.040.40
Nederlandse titel Prothesen - Beproeving van de enkel-voethulpstukken en voetunits - Eisen en beproevingsmethoden
Engelse titel Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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