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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 036 Date of Entry 07/09/2014 
FR Recognition Number 14-435
Standard
ASTM  F2251-13 (Reapproved 2023)
Standard Test Method for Thickness Measurement of Flexible Packaging Material
Scope/Abstract
1.1 This test method covers the measurement of thickness of flexible packaging materials using contact micrometers.
1.2 The Precision and Bias statement for this test method was developed using both handheld and bench top micrometers with foot s ranging from 4.8 to 15.9 mm (3/16 to 5/8 in.).
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
 Steven Turtil
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-6305
  steven.turtil@fda.hhs.gov
 Matthew Beckwith
  CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3393
  Matthew.Beckwith@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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