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ASTM F86-21

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Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

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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.


3.1 The objective of surface treatments as documented in this practice is to improve the corrosion resistance of metallic surgical implants including, but not limited to, those manufactured from iron, cobalt, nickel, titanium, and tantalum base materials.

3.2 Iron particles, ceramic media, and other foreign particles may become smeared over or embedded into the surface of implants during processing operations such as forming, machining, tumbling, media blasting, marking, and so forth. These particles should be removed to minimize localized corrosion and superficial blemishes.

3.3 The various chemical and electrochemical surface treatments specified by this practice are used to remove objectionable surface contaminants and to restore maximum corrosion resistance to, or promote the creation of, an inert or passive surface, such as a metal oxide film, as is applicable to the specific material. Some of these treatments are referred to as passivation treatments. The preferred surface treatment for a given application varies depending on the implant material and the nature of the surface contaminants.

3.4 Depending on the implant, its material, and the type of marking method and procedure, the marking may be applied before or after a chemical or electrochemical surface treatment. When marking is performed after the surface treatment, the localized implant surface shall be evaluated to determine if there is a need for additional surface treatment.

Note 1: The need for additional surface treatment is likely for stainless steel with all marking methods, and for nonferrous alloys when the marking method involves direct or second-hand contact with iron-based or other material that would be considered an objectionable surface contaminant.

3.5 The selection of procedures to be applied to the implants, and additional requirements which are not covered by this practice, may be included in the implant production specification.

SDO ASTM: ASTM International
Document Number F86
Publication Date June 1, 2021
Language en - English
Page Count 5
Revision Level 21
Supercedes
Committee F04.12
Publish Date Document Id Type View
June 1, 2021 F0086-21 Revision
June 1, 2013 F0086-13 Revision
Dec. 1, 2012 F0086-12A Revision
May 15, 2012 F0086-12 Revision
Oct. 1, 2004 F0086-04 Revision
Jan. 10, 2001 F0086-01 Revision
Jan. 10, 2001 F0086-00 Revision
Dec. 1, 2009 F0086-04R09 Reaffirmation