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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 16-231
ISO  10328 Second edition 2016-06-01
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
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 the components of loading which normally occur at different instants during the stance phase of walking.

The tests described in this International Standard comprise
- principal static and cyclic tests for all components;
- a separate static test in torsion for all components;
- separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;
- a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;
- separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.

The tests described in this International Standard apply to specific types of ankle-disarticulation prostheses (see NOTE 2), to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses (see NOTE 3)...
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3475 Sling, Arm, Overhead Supported Class 1 ILE
§890.3475 Stocking, Elastic Class 1 ILG
§890.3475 Splint, Hand, And Components Class 1 ILH
§890.3475 Support, Arm Class 1 IOY
§890.3475 Orthosis, Limb Brace Class 1 IQI
§890.3475 Cage, Knee Class 1 ITM
§890.3475 Joint, Knee, External Brace Class 1 ITQ
§890.3475 Joint, Hip, External Brace Class 1 ITS
§890.3475 Joint, Ankle, External Brace Class 1 ITW
§890.3475 Orthosis, Corrective Shoe Class 1 KNP
§890.3475 Orthosis, Foot Drop Class 1 OHI
§890.3480 Powered Exoskeleton Class 2 PHL
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ozell Sanders
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.