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

SS-EN-ISO-10328 - 2016 EDITION - CURRENT
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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

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

11.180.10 (Aids and adaptation for moving Including wheelchairs, walking sticks and lifting platforms)


Medical devices

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Designation Name

SS-EN ISO 10328:2016

Revision Level

2016 EDITION

Status

Current

Publication Date

June 29, 2016

Language(s)

English

Page Count

160

International Equivalent

EN ISO 10328:2016(IDT); ISO 10328:2016(IDT)