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

SS-EN-ISO-22675 - 2016 EDITION - CURRENT
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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.

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Medical devices

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Designation Name

SS-EN ISO 22675:2016

Revision Level

2016 EDITION

Status

Current

Publication Date

June 29, 2016

Language(s)

English

Page Count

108

International Equivalent

EN ISO 22675:2016(IDT); ISO 22675:2016(IDT)