ASTM F86-00

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

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 is not specified in this practice. Surface requirements and marking methods included in the implant specification shall take precedence over requirements listed in this practice, where appropriate.  
1.2  This standard does not purport to address all of the safety problems, 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.

General Information

• Status: Historical
• Publication Date: 09-Jan-2001
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaced By: ASTM F86-01 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 10-Jan-2001
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 10-Jan-2001
• Referred By: ASTM F366-17 - Standard Specification for Fixation Pins and Wires
• Effective Date: 10-Jan-2001
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 10-Jan-2001
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Jan-2001
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 10-Jan-2001
• Referred By: ASTM F983-86(2018) - Standard Practice for Permanent Marking of Orthopaedic Implant Components
• Effective Date: 10-Jan-2001
• Referred By: ASTM F746-04(2021) - Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
• Effective Date: 10-Jan-2001
• Referred By: ASTM F452-76(2022) - Standard Specification for Preformed Cranioplasty Plates
• Effective Date: 10-Jan-2001
• Referred By: ASTM F1801-20 - Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
• Effective Date: 10-Jan-2001
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 10-Jan-2001
• Referred By: ASTM F3143-20 - Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
• Effective Date: 10-Jan-2001
• Referred By: ASTM F1350-15 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
• Effective Date: 10-Jan-2001
• Referred By: ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
• Effective Date: 10-Jan-2001
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 10-Jan-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 86 – XX
Standard Practice for
Surface Preparation and Marking of Metallic Surgical
Implants
This standard is issued under the fixed designation F 86; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.3 The various chemical and electrochemical surface treat-
ments specified in this standard are intended to remove
1.1 This practice provides a description of surface charac-
objectionable surface contaminants and to restore maximum
teristics, methods of surface preparation, and methods of
corrosion resistance to the passive oxide film.
marking for metallic surgical implants. Marking nomenclature
3.4 The need for an additional implant surface treatment
is not specified in this practice. Surface requirements and
such as secondary passivation in nitric acid should be evaluated
marking methods included in the implant specification shall
for localized implant surfaces that have electrochemical or
take precedence over requirements listed in this practice, where
laser product markings created after the final surface treatment.
appropriate.
1.2 This standard does not purport to address all of the
4. Description of Acceptable Surface Characteristics
safety concerns, if any, associated with its use. It is the
4.1 Metallic implants, when inspected in accordance with
responsibility of the user of this standard to establish appro-
this practice, shall be free of surface imperfections such as
priate safety and health practices and determine the applica-
toolmarks, nicks, scratches, cracks, cavities, burrs, and other
bility of regulatory limitations prior to use.
defects that would impair the serviceability of the device. The
2. Referenced Documents surfaces shall be cleaned to minimize the presence of foreign
material.
2.1 ASTM Standards:
4.2 Specific finish requirements such as texture, surface
A 380 Practice for Cleaning and Descaling Stainless Steel
roughness, or additional surface treatments shall be included in
Parts, Equipment, and Systems
the implant production specification.
A 967 Specification for Chemical Passivation Treatments
4.3 The implants shall be given a final surface treatment
for Stainless Steel Parts
according to Section 7.
B 600 Guide for Descaling and Cleaning Titanium and
Titanium Alloy Surfaces
5. Cleaning
F 983 Practice for Permanent Marking of Orthopaedic Im-
4 5.1 The surface of the implants shall be cleaned to minimize
plant Components
foreign material.
3. Significance and Use 5.2 The cleaning operations employed shall relate to the
following as appropriate:
3.1 The surface treatments documented in this specification
5.2.1 A method such as organic solvent degreasing for the
are intended to improve the corrosion resistance of metallic
removal of oils, greases, and other loose surface contaminants.
surgical implants manufactured from iron, cobalt, titanium, and
tantalum base materials.
NOTE 1—Anhydrous methanol and other solvents known to cause
3.2 Iron particles, ceramic media, and other foreign particles
environmentally assisted cracking of titanium and its alloys should be
avoided.
may become smeared over or imbedded into the surface of
implants during processing operations such as forming, ma-
5.2.2 A method such as one of the following for the removal
chining, tumbling, bead blasting, etc. These particles should be
of adherent foreign material, if necessary.
removed in order to minimize localized rust formation and
5.2.2.1 Hot alkaline cleaner used as recommended.
superficial blemishes.
5.2.2.2 Alkaline cleaner applied electrochemically as rec-
ommended.
This practice is under the jurisdiction of ASTM Committee F04 on Medical and
NOTE 2—Avoid cathodic cleaning of metals known to be susceptible to
Surgical Materials and Devices and is the direct responsibility of Subcommittee
hydrogen contamination and anodic cleaning of metals known to be
F04.12 on Metallurgical Materials.
susceptible to pitting. In addition, testing should be considered to confirm
Current edition approved XXXX, 2000. Published December 2000. Originally
that acidic cleaning will not affect the mechanical properties of alloys
published as F 86 – 84. Last previous edition F 86 – 00.
Annual Book of ASTM Standards, Vol. 01.03. susceptible to hydrogen contamination effects.
Annual Book of ASTM Standards, Vol. 02.04.
4 5.2.2.3 Ultrasonically agitated cleaning agent.
Annual Book of ASTM Standards, Vol. 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F86
5.2.3 An acidic cleaning process may be employed. For 7. Final Surface Treatment
titanium, titanium alloys and tantalum some possible cleaning
7.1 Implants shall be given a final surface treatment before
processes may be found in Practice B 600.
they are packaged.
7.2 Final surface treatments for materials specified under
NOTE 3—Prior to an acidic cleaning, degreasing shall be considered
section 2.1 are as follows:
where appropriate, in order to make the acidic cleaning effective in a
uniform manner.
7.2.1 Immerse in 20 to 45 volume % nitric acid (specific
gravity 1.1197 to 1.285) at room temperature for a minimum of
5.2.3.1 If acidic cleaning methods are used, this shall be
30 min. For an accelerated process, a 20 to 25 % acid solution,
stated in the implant production specification.
heated at 120 to 140°F (40 to 60°C), may be used for a
5.3 A neutralizing treatment shall be carried out where
minimum of 20 min. (See Specification A 967 and Practice
appropriate.
A 380).
5.4 An adequate rinsing operation shall be carried out.
This treatment provides passivation by surface oxidation,
5.5 An adequate drying cycle shall follow.
and is able to dissolve certain foreign material that might be
6. Product Marking
present from previous operations; it is therefore particularly
recommended when no other treatments take place that would
6.1 Markings are applied to the implant surfaces to provide
remove such foreign material.
traceability if the size and configuration of the implant are
7.2.2 Employ a neutralizing procedure for product designs
sufficient for such markings. To minimize potential adverse
where acidic liquid could be trapped.
effects, it
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