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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.
1.1 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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 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)