標準號：ISO 10328-2006
中文標準名稱：修復術.假腿的結構試驗.要求和試驗方法
英文標準名稱：Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
標準類型：C45
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.40;11.180.10
適用范圍：IMPORTANT — This International Standard is suitable for the assessment of the conformity of lowerlimb 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 demonstratedtheir compliance with the strength requirements specified in 4.4 of EN 12523:1999 through submissionto the relevant tests of ISO 10328:1996, need not be retested to ISO 22675:2006.This International Standard 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. Thecompound loads in the test sample relate to the peak values of the components of loading which normallyoccur at different instants during the stance phase of walking.The tests described in this International Standard 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 singlecomponents 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 forall knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop ona complete prosthesis;? separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in theextended position of the knee unit or knee-shin-assembly.The tests described in this International Standard apply to specific types of ankle-disarticulation prostheses(see NOTE 3), to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses andto the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses (see NOTE 4).NOTE 1 ISO 22523 (formerly EN 12523) addresses those of the Essential Requirements listed in Annex 1 of theEuropean Medical Device Directive 93/42/EEC that are applicable to external limb prostheses and external orthoses.NOTE 2 The tests can be performed on complete structures, on part structures or on individual components.NOTE 3 The tests only apply to ankle-disarticulation prostheses which include (foot) components of prosthetic anklefootdevices taken from the normal production line.NOTE 4 The distal part comprises the knee unit, the ankle-foot device and all parts between. Tests on hip units aredescribed in ISO 15032.