ASTM F86 - 13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

ASTM F86 - 13

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

Active Standard ASTM F86 | Developed by Subcommittee: F04.12

Book of Standards Volume: 13.01

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Significance and Use

3.1 The surface treatments documented in this practice are intended to improve the corrosion resistance of metallic surgical implants manufactured from iron, cobalt, titanium, and tantalum base materials.

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

3.3 The various chemical and electrochemical surface treatments specified in this practice are intended to remove objectionable surface contaminants and to restore maximum corrosion resistance to the passive oxide film.

3.4 The need for an additional implant surface treatment such as secondary passivation in nitric acid should be evaluated for localized implant surfaces that have electrochemical or laser product markings created after the final surface treatment.

1. Scope

1.1 This practice provides a description of surface characteristics, methods of surface preparation, and methods of marking for metallic surgical implants. Marking nomenclature and neutralization of endotoxin are not specified in this practice (see X1.3). Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate.

1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

1.3 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.

ASTM Standards

A380 Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems

A967 Specification for Chemical Passivation Treatments for Stainless Steel Parts

B600 Guide for Descaling and Cleaning Titanium and Titanium Alloy Surfaces

F983 Practice for Permanent Marking of Orthopaedic Implant Components

ICS Code

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

UNSPSC Code

UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)

Referencing This Standard

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DOI: 10.1520/F0086

Citation Format

ASTM F86-13, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants, ASTM International, West Conshohocken, PA, 2013, www.astm.org