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Significance and Use
This test method is designed solely for determining comparative laboratory indices of performance. The results may be used for ranking alloys in order of increasing resistance to pitting and crevice corrosion under the specific conditions of this method. It should be noted that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown of at least one alloy (Type 316 L stainless steel) currently considered acceptable for surgical implant use, and that those alloys which suffer pitting or crevice corrosion during the more severe portions of the test do not necessarily suffer localized corrosion when placed within the human body as a surgical implant.
1.1 This test method covers the determination of resistance to either pitting or crevice corrosion of metals and alloys from which surgical implants will be produced. It is a modified version of an established test and is used as a screening test to rank surgical implant alloys in order of their resistance to localized corrosion.
1.2 This test method applies only to passive metals and alloys. Nonpassive alloys (other than noble alloys) are susceptible to general corrosion and are not normally suitable for implant use.
1.3 This test method is intended for use as a laboratory screening test for metals and alloys which undergo pitting or crevice corrosion, or both.
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
1.5 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D1193 Specification for Reagent Water
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F2129 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
G3 Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
G5 Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements
G15 Terminology Relating to Corrosion and Corrosion Testing
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)