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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 050 Date of Entry 09/17/2018 
FR Recognition Number 8-412
Standard
ASTM  F2537-06 (Reapproved 2017)
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
Scope/Abstract
1.1 This practice covers the procedures for calibration of linear displacement sensors and their corresponding power supply, signal conditioner, and data acquisition systems (linear displacement sensor systems) for use in measuring micromotion. It covers any sensor used to measure displacement that gives an electrical voltage output that is linearly proportional to displacement. This includes, but is not limited to, linear variable differential transformers (LVDTs) and differential variable reluctance transducers (DVRTs).
1.2 This calibration procedure is used to determine the relationship between output of the linear displacement sensor system and displacement. This relationship is used to convert readings from the linear displacement sensor system into engineering units.
1.3 This calibration procedure is also used to determine the error of the linear displacement sensor system over the range of its use.
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.
Transition Period
FDA recognition of ASTM F2537-06 (Reapproved 2017) [Rec# 8-412] will be superseded by recognition of ASTM F2537-23 [Rec# 8-606]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-412] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-412] will not be accepted.
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
 Terry O. Woods
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@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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