| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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046
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Date of Entry 12/23/2016
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FR Recognition Number
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8-441
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| Standard | |
ASTM F3109-16
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
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Scope/Abstract1.1 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. |
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| Extent of Recognition
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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.
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Transition Period
| FDA recognition of ASTM F3109-16 [Rec# 8-441] will be superseded by recognition of ASTM F3109-22 [Rec# 8-598]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-441] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 8-441] will not be accepted. |
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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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
