ISO 22675:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
05-12-2024
English, French
26-05-2016
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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.
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.
| Committee |
ISO/TC 168
|
| DevelopmentNote |
Supersedes ISO/DIS 22675. (05/2016)
|
| DocumentType |
Standard
|
| Pages |
91
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| NF EN ISO 22675 : 2016 | Identical |
| NBN EN ISO 22675 : 2016 | Identical |
| NEN EN ISO 22675 : 2016 | Identical |
| NS EN ISO 22675 : 2006 | Identical |
| I.S. EN ISO 22675:2016 | Identical |
| PN EN ISO 22675 : 2016 | Identical |
| SN EN ISO 22675 : 2016 | Identical |
| UNI EN ISO 22675 : 2007 | Identical |
| SS-EN ISO 22675:2016 | Identical |
| UNI EN ISO 22675 : 2016 | Identical |
| UNE-EN ISO 22675:2017 | Identical |
| BS EN ISO 22675:2006 | Identical |
| EN ISO 22675:2016 | Identical |
| DIN EN ISO 22675:2016-12 | Identical |
| GOST R ISO 22675 : 2009 | Identical |
| BS EN ISO 22675:2016 | Identical |
| SAC GB/T 31181 : 2014 | Identical |
| 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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