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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Entry 12/23/2016 
FR Recognition Number 8-441
Standard
ASTM F3109-16
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
Scope/Abstract
1.1 This standard specifies procedures for performance verification of multi-axis force platforms commonly used for measuring ground reaction forces during gait, balance and other activities.

1.1.1 This standard provides a method to quantify the relationship between applied input force and force platform output signals across the manufacturer's defined spatial working surface and specified force operating range.

1.1.2 This standard provides definitions of the critical parameters necessary to quantify the behavior of multi-axis force measuring platforms and the methods to measure the parameters.

1.1.3 This standard presents methods for the quantification of spatially distributed errors and absolute measuring performance of the force platform at discrete spatial intervals and discrete force levels on the working surface of the platform.

1.1.4 This standard further defines certain important derived parameters, notably COP (center of pressure) and methods to quantify and report the measuring performance of such derived parameters at spatial intervals and force levels across the working range of the force platform.

1.1.5 This standard defines the requirements for a report suitable to characterize the force platform's performance and provide traceable documentation to be distributed by the manufacturer or calibration facility to the users of such platforms.

1.1.6 Dynamic characteristics and applications where the force platform is incorporated in other equipment, such as instrumented treadmills and stairs, are beyond the scope of this standard.

1.1.7 This standard is written for purposes of multi-axis force platform verification; however the methods and procedures are applicable to calibration of force platforms by manufacturers.
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.
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 Contacts
 Terry O. Woods
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@fda.hhs.gov
 James Coburn
  FDA/OC/OCS/OCET/
  301-796-0286
  james.coburn@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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