30.98 Project deleted Dec 13, 2010
CEN
CEN/TC 293 Assistive products and accessibility
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
ISO 10328:2005 specifies procedures for static and cyclic strength tests on lower-limb prostheses where, with one exception, compound loadings are produced 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.
The tests described in ISO 10328:2005 comprise:
principal static and cyclic tests for all components;a separate static test in torsion for all components;separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.
The tests described in this ISO 10328:2005 apply to specific types of ankle-disarticulation prostheses, to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN ISO 10328:2006
ABANDON
prEN ISO 10328
30.98
Project deleted
Dec 13, 2010
