Standard Swedish standard · SS-EN ISO 10328:2016

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)

Status: Valid

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Standard Swedish standard · SS-EN ISO 10328:2016

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
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Scope
IMPORTANT — This International Standard 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 — This International Standard 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.
This International Standard 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

Subjects

Implants for surgery, prosthetics and orthotics (11.040.40)


Buy this standard

Standard Swedish standard · SS-EN ISO 10328:2016

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
Subscribe on standards - Read more Dölj
Price: 1 847 SEK
standard ikon pdf

PDF

Price: 1 847 SEK
standard ikon

Paper

Price: 2 955,20 SEK
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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8021172

Edition: 2

Approved: 6/29/2016

No of pages: 160

Replaces: SS-EN ISO 10328:2006