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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 056 Date of Entry 06/07/2021 
FR Recognition Number 8-557
Standard
ASTM F3268-18a
Standard Guide for in vitro Degradation Testing of Absorbable Metals
Scope/Abstract
1.1 The purpose of this standard is to outline appropriate experimental approaches for conducting an initial evaluation of the in vitro degradation properties of a device or test sample fabricated from an absorbable metal or alloy.

1.2 The described experimental approaches are intended to control the corrosion test environment through standardization of conditions and utilization of physiologically relevant electrolyte fluids. Evaluation of a standardized degradation control material is also incorporated to facilitate comparison and normalization of results across laboratories.
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FDA recognition of ASTM F3268-18 [Rec# 8-486] will be superseded by recognition of ASTM F3268-18a [Rec# 8-557]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-486] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 8-486] will not be accepted.
FDA Technical Contact
 Shiril Sivan
  FDA/OC/CDRH/OSEL/DAM/
  240-402-4125
  Shiril.Sivan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
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