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Significance and Use
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.
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 ).
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
USP StandardUSP General Chapter <161>
ISO StandardISO 10993-11:2017 Biological Evaluation of Medical DevicesPart 11: Tests for Systemic Toxicity, Annex G
A380/A380M Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
A967/A967M Specification for Chemical Passivation Treatments for Stainless Steel Parts
B600 Guide for Descaling and Cleaning Titanium and Titanium Alloy Surfaces
B912 Specification for Passivation of Stainless Steels Using Electropolishing
E2148 Guide for Using Documents Related to Metalworking or Metal Removal Fluid Health and Safety
E2275 Practice for Evaluating Water-Miscible Metalworking Fluid Bioresistance and Antimicrobial Pesticide Performance
E2657 Practice for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
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)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F86-21, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants, ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top