ASTM F86-04(2009)
(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
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.
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.
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.
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:F86–04 (Reapproved 2009)
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.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 charac-
3.2 Ironparticles,ceramicmedia,andotherforeignparticles
teristics, methods of surface preparation, and methods of
may become smeared over or imbedded into the surface of
marking for metallic surgical implants. Marking nomenclature
implants during processing operations such as forming, ma-
andneutralizationofendotoxinarenotspecifiedinthispractice
chining, tumbling, bead blasting, and so forth. These particles
(see X1.3). Surface requirements and marking methods in-
should be removed to minimize localized rust formation and
cluded in the implant specification shall take precedence over
superficial blemishes.
requirements listed in this practice, where appropriate.
3.3 The various chemical and electrochemical surface treat-
1.2 The values stated in inch-pound units are to be regarded
ments specified in this practice are intended to remove objec-
as standard. The values given in parentheses are mathematical
tionable surface contaminants and to restore maximum corro-
conversions to SI units that are provided for information only
sion resistance to the passive oxide film.
and are not considered standard.
3.4 The need for an additional implant surface treatment
1.3 This standard does not purport to address all of the
suchassecondarypassivationinnitricacidshouldbeevaluated
safety concerns, if any, associated with its use. It is the
for localized implant surfaces that have electrochemical or
responsibility of the user of this standard to establish appro-
laser product markings created after the final surface treatment.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Description of Acceptable Surface Characteristics
2. Referenced Documents 4.1 Metallic implants, when inspected in accordance with
2 this practice, shall be free of surface imperfections such as
2.1 ASTM Standards:
toolmarks, nicks, scratches, cracks, cavities, burrs, and other
A380 Practice for Cleaning, Descaling, and Passivation of
defects that would impair the serviceability of the device. The
Stainless Steel Parts, Equipment, and Systems
surfaces shall be cleaned to minimize the presence of foreign
A967 Specification for Chemical Passivation Treatments
material.
for Stainless Steel Parts
4.2 Specific finish requirements such as texture, surface
B600 Guide for Descaling and Cleaning Titanium and
roughness, or additional surface treatments shall be included in
Titanium Alloy Surfaces
the implant production specification.
F983 Practice for Permanent Marking of Orthopaedic Im-
4.3 The implants shall be given a final surface treatment
plant Components
according to Section 7.
3. Significance and Use
5. Cleaning
3.1 The surface treatments documented in this practice are
5.1 Thesurfaceoftheimplantsshallbecleanedtominimize
intended to improve the corrosion resistance of metallic
foreign material.
5.2 The cleaning operations used shall relate to the follow-
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
ing as appropriate:
Surgical Materials and Devices and is the direct responsibility of Subcommittee
5.2.1 A method such as organic solvent degreasing for the
F04.12 on Metallurgical Materials.
removal of oils, greases, and other loose surface contaminants.
Current edition approved Dec. 1, 2009. Published December 2009. Originally
approved in 1984. Last previous edition approved in 2004 as F86 – 04. DOI:
NOTE 1—Anhydrous methanol and other solvents known to cause
10.1520/F0086-04R09.
environmentally assisted cracking of titanium and its alloys should be
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
avoided.
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.
F86–04 (2009)
5.2.2 Amethodsuchasoneofthefollowingfortheremoval 6.5.5 Marking with vibrator-type contact,
of adherent foreign material, if necessary. 6.5.6 Electro-pencil marking, and
5.2.2.1 Hot alkaline cleaner used as recommended. 6.5.7 Marking with laser beam.
5.2.2.2 Alkaline cleaner applied electrochemically as rec- 6.6 Depending on the implant, its material, and the type of
ommended. marking method and procedure, the marking may be applied
before or after the final surface treatment. (See 7.6).
NOTE 2—Avoid cathodic cleaning of metals known to be susceptible to
hydrogen contamination and anodic cleaning of metals known to be
7. Final Surface Treatment
susceptible to pitting. In addition, testing to confirm that acidic cleaning
7.1 Implants shall be given a final surface treatment before
will not affect the mechanical properties of alloys susceptible to hydrogen
they are packaged.
contamination effects should be considered .
7.2 Final surface treatments are as follows:
5.2.2.3 Ultrasonically agitated cleaning agent.
7.2.1 Immerse in 20 to 45 volume % nitric acid (specific
5.2.3 An acidic cleaning process may be used. For titanium,
gravity1.1197to1.285)atroomtemperatureforaminimumof
titanium alloys, and tantalum, some possible cleaning pro-
30 min. For an accelerated process, a 20 to 25 % acid solution,
cesses may be found in Guide B600.
heated to 120 to 140°F (49 to 60°C), may be used for a
NOTE 3—Before an acidic cleaning, degreasing shall be considered
minimum of 20 min. (See Specification A967 and Practice
where appropriate to make the acidic cleaning effective in a uniform
A380).
manner.
7.2.1.1 This treatment provides passivation by surface oxi-
5.2.3.1 If acidic cleaning methods are used, this shall be
dation and can dissolve certain foreign material that might be
stated in the implant production specification.
present from previous operations; it is therefore particularly
5.3 A neutralizing treatment shall be carried out where
recommended when no other treatments that would remove
appro
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