ASTM F0086-21 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
|Keywords:||alkaline cleaners; cleaning; electropolishing; final inspections; markings; metal implants; passivation; surface treatments;|
1.1 This practice provides descriptions of surface characteristics, surface preparation, and marking for metallic surgical implants, with the purpose of improving the corrosion resistance of the implant surfaces and markings.
1.2 Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.4).
1.3 Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate.
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 nonconformance 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 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.