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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 041 Date of Entry 04/04/2016 
FR Recognition Number 8-107
Standard
ASTM  F746-04 (Reapproved 2014)
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
Scope/Abstract
1.1 This test method covers the determination of resistance to either pitting or crevice corrosion of metals and alloys from which surgical implants will be produced. It is a modified version of an established test2 and is used as a screening test to rank surgical implant alloys in order of their resistance to localized corrosion.

1.2 This test method applies only to passive metals and alloys. Nonpassive alloys (other than noble alloys) are susceptible to general corrosion and are not normally suitable for implant use.

1.3 This test method is intended for use as a laboratory screening test for metals and alloys which undergo pitting or crevice corrosion, or both.
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.
Public Law, CFR Citation(s) and Procode(s)*
Implantable Medical Devices
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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