【国外标准】 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

4.1 It is well known from examination of implants after use that plates and screws used for osteosynthesis are subjected to metal loss due to corrosion at the plate-screw interfaces. One of the mechanisms of this corrosive attack is fretting corrosion due to relative motion (micromotion) between the screw heads and plate-hole countersinks.4.2 It is also known that release of corrosion products into the tissues surrounding an implant may have adverse effects on local tissue or have systemic effects. Thus, it is important to minimize the amount of tissue exposure to corrosion products.4.3 Screws and plates are available in different configurations in accordance with Specifications F543 and F382. This test method may be used to evaluate the effects of different combinations of screw and plate designs. As new materials and device designs are developed for use in the treatment of fractured bones, it is important to determine the effects these developments have on the amount of metal loss due to fretting corrosion.4.4 This test method provides a standardized screening test for ranking metal plates and screws in terms of resistance to fretting corrosion and for determining the influence of different solutions on fretting corrosion rates.4.5 This test method may also be used to generate corrosion products either for chemical analysis of the products or for testing for biological reactions to corrosion products using animal or cell culture methods.4.6 It is well known that fretting corrosion rates depend on normal load or pressure, frequency, sliding amplitude, materials, surface treatments, and environmental factors. (4) Therefore, when determining the effect of changing one of these parameters (for example, material or environment), all others must be kept constant to facilitate interpretation of the results.1.1 This test method provides a screening test for determining the amount of metal loss from plates and screws used for osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate hole countersink area. The implants are used in the form they would be used clinically. The machine described generates a relative motion between plates and screws which simulates one type of motion pattern that can occur when these devices are used clinically.1.2 Since the environmental and stress conditions used in this test method may not be identical to those experienced by bone plates in the human body, this test method may produce fretting corrosion rates that are lower or higher than those experienced in practice. The recommended axial load of 400 N was selected as being in a range where the amount of fretting corrosion is not sensitive to small changes in axial load (1).2 The combination of the recommended load and angular displacement are such that a measurable amount of fretting corrosion of surgical alloys occurs in a comparatively short period of time (7 to 14 days). (Refs 1-3)1.3 The device is designed so as to facilitate sterilization of the test specimens and test chambers to permit testing with proteinaceous solutions that would become contaminated with microbial growth in nonsterile conditions.1.4 The specimens used can be standard osteosynthesis implants or can be materials fabricated into the appropriate shapes.1.5 This test method may be used for testing the fretting corrosion of metal plates and screws of similar or different alloy compositions, or it may be used for testing the fretting corrosion of metal-nonmetal combinations. This test method may also be used for wear or degradation studies of nonmetallic materials. This test method may be used as a screening test to rank the corrosivities of saline or proteinaceous solutions, or to rank metal-to-metal couples for resistance to fretting corrosion, or to study other material combinations.1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.1.7 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.1.8 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.