1. Scope

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) . 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 SI units are to be regarded as the standard. The values given in parentheses are for information only.

This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns associated with its use. It is the responsibility of whoever uses this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D1886 Test Methods for Nickel in Water

F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

F382 Specification and Test Method for Metallic Bone Plates

F543 Specification and Test Methods for Metallic Medical Bone Screws

G1 Practice for Preparing, Cleaning, and Evaluating Corrosion Test Specimens

Keywords

corrosion-surgical implants; cracking-stress-corrosion; loading tests-surgical materials/applications; orthopaedic medical devices-bone plates; orthopaedic medical devices-bone screws; osteosynthesis; seals; stress-metallic materials; testing methods-surgical implants;

ICS Code

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

DOI: 10.1520/F0897-02R07

ASTM International is a member of CrossRef.