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  • ASTM
    F2129-24 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices (Redline)
    Edition: 2024
    $103.58
    Unlimited Users per year

Description of ASTM-F2129 2024

ASTM F2129-24

Redline Standard: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices




ASTM F2129

Scope

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.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Keywords

corrosion; cyclic polarization; medical device testing; pitting potential; protection potential; rest potential;


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F2129-24

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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