Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 8-624
Standard
ASTM  F2129-24
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Scope/Abstract
1.1 This test method assesses the corrosion susceptibility of small metallic implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization. Examples of device types that may be evaluated by this test method include, but are not limited to, vascular stents, ureteral stents (Specification F1828), filters, support segments of endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and so forth.

1.2 This test method is used to assess a device in its final form and finish, as it would be implanted. These small devices should be tested in their entirety. The upper limit on device size is dictated by the electrical current delivery capability of the test apparatus (see Section 6). It is assumed that test methods such as Reference Test Method G5 and Test Method G61 have been used for material screening.

1.3 Because of the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations.

1.4 This test method is intended for use on implantable devices made from metals with a relatively high resistance to corrosion.
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FDA recognition of ASTM F2129-19a [Rec# 8-522] will be superseded by recognition of ASTM F2129-24 [Rec# 8-624]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-522] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-522] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
1. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol-Guidance for Industry and Food and Drug Administration Staff, issued July 2021.

2. Guidance for Industry and Food and Drug Administration Staff: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued August 2015.

3. Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions-Guidance for Industry and Food and Drug Administration Staff, issued July 2019.

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
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
 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
*These are provided as examples and others may be applicable.
-
-