ASTM F86-12a
(Practice)Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
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.
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.
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Designation: F86 − 12a
StandardPractice for
Surface Preparation and Marking of Metallic Surgical
1
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.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope* surgicalimplantsmanufacturedfromiron,cobalt,titanium,and
tantalum base materials.
1.1 This practice provides a description of surface
characteristics,methodsofsurfacepreparation,andmethodsof 3.2 Ironparticles,ceramicmedia,andotherforeignparticles
marking for metallic surgical implants. Marking nomenclature
may become smeared over or imbedded into the surface of
andneutralizationofendotoxinarenotspecifiedinthispractice implants during processing operations such as forming,
(see X1.3). Surface requirements and marking methods in-
machining, tumbling, bead blasting, and so forth. These par-
cluded in the implant specification shall take precedence over ticles should be removed to minimize localized rust formation
requirements listed in this practice, where appropriate.
and superficial blemishes.
1.2 The values stated in inch-pound units are to be regarded
3.3 The various chemical and electrochemical surface treat-
as standard. The values given in parentheses are mathematical
ments specified in this practice are intended to remove objec-
conversions to SI units that are provided for information only
tionable surface contaminants and to restore maximum corro-
and are not considered standard.
sion resistance to the passive oxide film.
1.3 This standard does not purport to address all of the
3.4 The need for an additional implant surface treatment
safety concerns, if any, associated with its use. It is the
suchassecondarypassivationinnitricacidshouldbeevaluated
responsibility of the user of this standard to establish appro-
for localized implant surfaces that have electrochemical or
priate safety and health practices and determine the applica-
laser product markings created after the final surface treatment.
bility of regulatory limitations prior to use.
4. Description of Acceptable Surface Characteristics
2. Referenced Documents
2
4.1 Metallic implants, when inspected in accordance with
2.1 ASTM Standards:
this practice, shall be free of surface imperfections such as
A380 Practice for Cleaning, Descaling, and Passivation of
toolmarks, nicks, scratches, cracks, cavities, burrs, and other
Stainless Steel Parts, Equipment, and Systems
defects that would impair the serviceability of the device. The
A967 Specification for Chemical Passivation Treatments for
surfaces shall be cleaned to minimize the presence of foreign
Stainless Steel Parts
material.
B600 Guide for Descaling and Cleaning Titanium and Tita-
nium Alloy Surfaces
4.2 Specific finish requirements such as texture, surface
F983 Practice for Permanent Marking of Orthopaedic Im-
roughness, or additional surface treatments shall be included in
plant Components
the implant production specification.
3. Significance and Use 4.3 The implants shall be given an appropriate final surface
treatment according to Section 6.
3.1 The surface treatments documented in this practice are
intended to improve the corrosion resistance of metallic
5. Cleaning
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
5.1 Thesurfaceoftheimplantsshallbecleanedtominimize
Surgical Materials and Devices and is the direct responsibility of Subcommittee
foreign material.
F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2012. Published December 2012. Originally
5.2 The cleaning operations used shall relate to the follow-
approved in 1984. Last previous edition approved in 2012 as F86 – 12. DOI:
ing as appropriate:
10.1520/F0086-12A.
2
5.2.1 A method such as organic solvent degreasing for the
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
removal of oils, greases, and other loose surface contaminants.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. NOTE 1—Anhydrous methanol and other solvents known to cause
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F86 − 12a
environmentally assisted cracking of titanium and its alloys should be
avoided.
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F86 − 12a
5.2.2 Amethodsuchasoneof
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
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 − 12 F86 − 12a
Standard Practice for
Surface Preparation and Marking of Metallic Surgical
1
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.
This standard has been approved for use by agencies of the Department of Defense.
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
2
2.1 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
3. 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.
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,
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.
1
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 May 15, 2012Dec. 1, 2012. Published May 2012December 2012. Originally approved in 1984. Last previous edition approved in 20092012 as
F86 – 04 (2009).F86 – 12. DOI: 10.1520/F0086-12.10.1520/F0086-12A.
2
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
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F86 − 12a
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.
5. Cleaning
5.1 The surface of the implants shall be cleaned to minimize foreign material.
5.2 The cleaning operations used shall relate
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