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ISO 22675:2016

Current
Current

The latest, up-to-date edition.

Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

26-05-2016

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.

DevelopmentNote
Supersedes ISO/DIS 22675. (05/2016)
DocumentType
Standard
Pages
91
PublisherName
International Organization for Standardization
Status
Current
SupersededBy
Supersedes

I.S. EN ISO 22523:2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
BS EN ISO 10328:2016 Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods
BS EN ISO 22523:2006 External limb prostheses and external orthoses. Requirements and test methods
EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
ISO/TS 16955:2016 Prosthetics — Quantification of physical parameters of ankle foot devices and foot units
I.S. EN ISO 10328:2016 PROSTHETICS - STRUCTURAL TESTING OF LOWER-LIMB PROSTHESES - REQUIREMENTS AND TEST METHODS (ISO 10328:2016)
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
03/317861 DC : DRAFT OCT 2003 EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
ISO 10328:2016 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
ISO/TR 22676:2006 Prosthetics Testing of ankle-foot devices and foot units Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment
13/30251846 DC : 0 BS ISO 16955 - PROSTHETICS - QUANTIFICATION OF PHYSICAL PARAMETERS OF ANKLE FOOT DEVICES AND FOOT UNITS
ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
UNE-EN ISO 10328:2017 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
EN ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
PD ISO/TS 16955:2016 Prosthetics. Quantification of physical parameters of ankle foot devices and foot units

ISO 10328:2016 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
ISO/TR 22676:2006 Prosthetics Testing of ankle-foot devices and foot units Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment
ISO 8549-1:1989 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

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