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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 047 Date of Entry 08/21/2017 
FR Recognition Number 8-458
Standard
ASTM G5-14
Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
Scope/Abstract
1.1 This test method covers an experimental procedure for checking experimental technique and instrumentation. If followed, this test method will provide repeatable potentiodynamic anodic polarization measurements that will reproduce data determined by others at other times and in other laboratories provided all laboratories are testing reference samples from the same lot of Type 430 stainless steel.
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
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@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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