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Recognized Consensus Standards
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Recognition List Number: 025 Publication Date: 10/04/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 17-9: ASTM F2129-08, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. (Neurology)

Date of Standard: 2008. 
Address of Standards Organization:
  ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Small metallic neurologic implants
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 National, Horizontal, Test Methods
Extent of Recognition:
Complete standard

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, which may be evaluated by this test method include, but are not limited to, vascular stents, 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 Test Methods G 5 and 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.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§882.5200 Clip, Aneurysm Class 2 HCH
 
Relevant Guidance:
Guidance for Testing MR Interactive with Aneurysm Clips, Draft Document - May 22, 1996
FDA Technical Contact:
  Peter L. Hudson, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 3618
  Silver Spring MD 20993
  301/796-6440
  Email: peter.hudson@fda.hhs.gov
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