ISO 10328:2016
Current
The latest, up-to-date edition.
Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
26-05-2016
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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.
| Committee |
ISO/TC 168
|
| DevelopmentNote |
Supersedes ISO 10328-1, ISO 10328-2, ISO 10328-3, ISO 10328-4, ISO 10328-5, ISO 10328-6, ISO 10328-7 and ISO 10328-8. (09/2006) Supersedes ISO/DIS 10328. (05/2016)
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| DocumentType |
Standard
|
| Pages |
148
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 10328 : 2016 | Identical |
| NBN EN ISO 10328 : 2016 | Identical |
| NEN EN ISO 10328 : 2016 | Identical |
| NS EN ISO 10328 : 2006 | Identical |
| I.S. EN ISO 10328:2016 | Identical |
| PN EN ISO 10328 : 2016 | Identical |
| SN EN ISO 10328:2016 | Identical |
| UNI EN ISO 10328 : 2007 | Identical |
| SS-EN ISO 10328 : 2016 | Identical |
| UNE-EN ISO 10328:2017 | Identical |
| BS EN ISO 10328:2016 | Identical |
| EN ISO 10328:2016 | Identical |
| DIN EN ISO 10328:2016-12 | Identical |
| UNI EN ISO 10328:2016 | Identical |
| GOST R ISO 10328 : 2007 | Identical |
| I.S. EN ISO 22523:2006 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| BS EN ISO 22523:2006 | External limb prostheses and external orthoses. Requirements and test methods |
| I.S. EN ISO 22675:2016 | PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016) |
| EN ISO 22523:2006 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| 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 |
| UNE-EN ISO 22675:2017 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) |
| 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/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/TS 16955:2016 | Prosthetics — Quantification of physical parameters of ankle foot devices and foot units |
| 13/30251846 DC : 0 | BS ISO 16955 - PROSTHETICS - QUANTIFICATION OF PHYSICAL PARAMETERS OF ANKLE FOOT DEVICES AND FOOT UNITS |
| ISO 22675:2016 | Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods |
| ISO 22523:2006 | External limb prostheses and external orthoses — Requirements and test methods |
| BS EN ISO 22675:2006 | Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods |
| EN ISO 22675:2016 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) |
| PD ISO/TS 16955:2016 | 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 |
| ISO 15032:2000 | Prostheses — Structural testing of hip units |
| 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 |
| ISO 22675:2016 | Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods |
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