ASTM F86-21

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it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F86 − 13 F86 − 21
Standard Practice for
Surface Preparation and Marking of Metallic Surgical
Implants
This standard is issued under the fixed designation F86; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
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 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.
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given in
parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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 safety, health, and healthenvironmental 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
2.1 ASTM Standards:
A380A380/A380M Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
A967A967/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
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12
on Metallurgical Materials.
Current edition approved June 1, 2013June 1, 2021. Published July 2013June 2021. Originally approved in 1984. Last previous edition approved in 20122013 as
F86 – 12a.F86 – 13. DOI: 10.1520/F0086-13.10.1520/F0086-21.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
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F86 − 21
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
2.2 ISO Standard:
ISO 10993-11:2017 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity, Annex G
2.3 USP Standard:
USP General Chapter <161> Medical Devices—Bacterial Endotoxin and Pyrogen Tests (2019)
2.4 FDA Document:
FDA Guidance for Industry: Pyrogens and Endotoxins Testing: Questions and Answers, 2012 (updated in 2019)
2.5 AAMI Standard:
AAMI ST72:2019 Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
3. Significance and Use
3.1 The objective of surface treatments as documented in this practice are intended 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 imbeddedembedded into the surface
of implants during processing operations such as forming, machining, tumbling, beadmedia blasting, marking, and so forth. These
particles should be removed to minimize localized rust formation corrosion and superficial blemishes.
3.3 The various chemical and electrochemical surface treatments specified inby this practice are intendedused to remove
objectionable surface contaminants and to restore maximum corrosion resistance to the passive oxide film.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 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 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.
4. Description of Acceptable Surface Characteristics
4.1 Metallic implants, when inspected in accordance with this practice, shall be free of surface imperfections such as toolmarks,
tool marks, nicks, scratches, cracks, cavities, burrs, and other defects that would impair the serviceability of the device. The
surfaces shall be cleaned to minimize the presence of foreign material.
4.2 Specific finish requirements such as texture, surface roughness, or additional surface treatments shall be included in the
implant production specification.
4.3 The implants shall be given an appropriate final surface treatment according to Section 6.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from U.S. Pharmacopeial Convention (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Available from U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
Available from Association for the Advancement of Medical Instrumentation (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://www.aami.org.
F86 − 21
5. Cleaning
5.1 The surface of the implants shall be cleaned to minimize foreign material.
5.2 The cleaning operations used shall relate to the following as appropriate:
5.2.1 A method such as organic solvent degreasing for the removal of oils, greases, and other loose surface contaminants.
NOTE 2—Anhydrous methanol and other solvents known to cause environmentally assisted cracking of titanium and its alloys should be avoided.
5.2.2 A method such as one of the following for the removal of adherent foreign material, if necessary.necessary:
5.2.2.1 Hot alkaline cleaner, used as recommended.
5.2.2.2 Alkaline cleaner applied electrochemically as recommended.
NOTE 3—Avoid cathodic cleaning of metals known to be susceptible to hydrogen contamination and anodic cleaning of metals known to be susceptible
to pitting. In addition, testing to confirm that acidic cleaning will not affect the mechanical properties of alloys susceptible to hydrogen contamination
effects should be considered .
5.2.2.3 Ultrasonically agitated cleaning agent.
5.2.3 An acidic cleaning process may be used. For titanium, titanium alloys, and tantalum, some possible cleaning processes may
be found in Guide B600.
NOTE 4—Before an acidic cleaning, degreasing shall be considered where appropriate to make the acidic cleaning effective in a uniform manner. In
addition, testing to confirm that acidic cleaning will not affect the mechanical properties of materials susceptible to hydrogen contamination effects, either
with or without a relief bake, should be considered.
5.2.3.1 If acidic cleaning methods are used, this shall be stated in the implant production specification.
5.3 A neutralizing treatment shall be carried out where appropriate.
5.4 An adequate rinsing operation shall be carried out.
5.5 An adequate drying cycle shall follow.
6. Final Surface Treatment
6.1 Implants shall be given a final surface treatment before they are packaged. packaged in order to create, restore, promote, or
otherwise ensure a passive surface. The surface treatment used should be specified in the production procedure documentation. A
number of different surface treatments are acceptable, including may be acceptable including, but not limited to, acid treatment,
electropolishing, anodizing, and oxidation. The following surface treatments are provided as examples, and this list should not be
considered restrictive:
NOTE 5—While this standard does not specify endotoxin neutralization, the manufacturer is responsible for appropriate monitoring and control of
endotoxin in cleaning and treatment baths, post-treatment testing for the presence of endotoxin and other residual contaminants that may present biological
hazards, and the elimination of such as appropriate. See X1.4.
6.2 Final nitric acid surface treatments are as follows:Certain acid treatments for the removal of surface free iron can provide
passive surface conditions for stainless steel, and also for nonferrous metals and alloys that possess or may possess iron
contamination on the implant surface. Such treatments provide passivation by surface oxidation and are able to dissolve certain
foreign material that might be present from previous operations; they are, therefore, particularly recommended when no other
treatments that would remove such foreign material take place. (See X1.3, Specification A967/A967M, and Practice
A380/A380M.)
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6.2.1 Example acid surface treatments are as follows:
6.2.2 Immerse in a 20 to 45 volume % nitric acid solution, at a temperature range from 20 to 30 °C [70 to 90 °F], for a minimum
of 30 min. This passivation treatment is equivalent to the Nitric 2 treatment in Specification A967/A967M.
6.2.3 Immerse in 20 to 45 volume % nitric acid at room temperature for a minimum of 30 min. The room temperature passivation
treatment is equivalent to the Nitric 2 treatment at a temperature range from 70 to 90°F (21 to 32°C) in Specification A967. For
an accelerated process, a 20 to 25 volume % n
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