Over deze norm
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 ), 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 ). It is assumed that test methods, such as Reference Test Method and Test Method 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 and health 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.
|Nederlandse titel||Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices|
|Engelse titel||Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices|