Need help?

EN ISO 22675:2016 Standard

wave
Save  

  Keywords:

#loading #static #strength #conditions #specified

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)

  Purpose

IMPORTANT ISO 22675:2016 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 ISO 22675:2016 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. ISO 22675:2016 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, ISO 22675:2016 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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 22675:2006"

Anyway is still possible use the "EN ISO 22675:2006" until June 30th, 2018

  Related Standards

EN 60601-2-3:1993

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipmentIEC 60601-2-3:1991

EN 62220-1-3:2008

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum...

EN 12470-2:2000+A1:2009

Medical devices Directive (93/42/EEC)

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

EN 13544-2:2002+A1:2009

Medical devices Directive (93/42/EEC)

Respiratory therapy equipment - Part 2: Tubing and connectors

EN 13544-3:2001+A1:2009

Medical devices Directive (93/42/EEC)

Respiratory therapy equipment - Part 3: Air entrainment devices

EN ISO 15883-4:2018

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 22675:2016 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0