DS/EN ISO 10328:2016

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 140.53
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

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.


Number of pages: 158

Published: 2016-08-25

Date of approval: 2016-07-20

International relationships : EN ISO 10328:2016 IDT ISO 10328:2016 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics 11.180.10 - Aids and adaptation for moving

Item number: M303491


Committees

Committee

  • CEN/TC 293
  • ISO/TC 168
  • ISO/TC 168/WG 3

Danish committee

DS/S-450