ASTM F86-01

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

• Replaces: ASTM F86-00 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 10-Jan-2001
• Replaced By: ASTM F86-04 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Oct-2004
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• 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• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)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 F746-04(2021) - Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
• 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 F452-76(2022) - Standard Specification for Preformed Cranioplasty Plates
• 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• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)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 F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• 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 F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 10-Jan-2001
• Referred By: ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
• 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

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
Designation: F 86 – 01
Standard Practice for
Surface Preparation and Marking of Metallic Surgical
1
Implants
ThisstandardisissuedunderthefixeddesignationF 86;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (ϵ) 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-
is not specified in this practice. Surface requirements and
chining, tumbling, bead blasting, and so forth. These particles
marking methods included in the implant specification shall
should be removed to minimize localized rust formation and
takeprecedenceoverrequirementslistedinthispractice,where
superficial blemishes.
appropriate.
3.3 The various chemical and electrochemical surface treat-
1.2 This standard does not purport to address all of the
ments specified in this standard are intended to remove
safety concerns, if any, associated with its use. It is the
objectionable surface contaminants and to restore maximum
responsibility of the user of this standard to establish appro-
corrosion resistance to the passive oxide film.
priate safety and health practices and determine the applica-
3.4 The need for an additional implant surface treatment
bility of regulatory limitations prior to use.
suchassecondarypassivationinnitricacidshouldbeevaluated
2. Referenced Documents
for localized implant surfaces that have electrochemical or
laser product markings created after the final surface treatment.
2.1 ASTM Standards:
A 380 Practice for Cleaning and Descaling Stainless Steel
4. Description of Acceptable Surface Characteristics
2
Parts, Equipment, and Systems
4.1 Metallic implants, when inspected in accordance with
A 967 Specification for Chemical Passivation Treatments
2 this practice, shall be free of surface imperfections such as
for Stainless Steel Parts
toolmarks, nicks, scratches, cracks, cavities, burrs, and other
B 600 Guide for Descaling and Cleaning Titanium and
3 defects that would impair the serviceability of the device. The
Titanium Alloy Surfaces
surfaces shall be cleaned to minimize the presence of foreign
F 983 Practice for Permanent Marking of Orthopaedic Im-
4 material.
plant Components
4.2 Specific finish requirements such as texture, surface
3. Significance and Use roughness, or additional surface treatments shall be included in
the implant production specification.
3.1 The surface treatments documented in this specification
4.3 The implants shall be given a final surface treatment
are intended to improve the corrosion resistance of metallic
according to Section 7.
5. Cleaning
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
5.1 The surface of the implants shall be cleaned to minimize
Surgical Materials and Devices and is the direct responsibility of Subcommittee
foreign material.
F04.12 on Metallurgical Materials.
Current edition approved Jan. 10, 2001. Published March 2001. Originally
5.2 The cleaning operations used shall relate to the follow-
published as F 86 – 84. Last previous edition F 86 – 00.
ing as appropriate:
2
Annual Book of ASTM Standards, Vol. 01.03.
3
5.2.1 A method such as organic solvent degreasing for the
Annual Book of ASTM Standards, Vol. 02.04.
4
Annual Book of ASTM Standards, Vol. 13.01. removal of oils, greases, and other loose surface contaminants.
*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.
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
F86–01
NOTE 1—Anhydrous methanol and other solvents known to cause
6.5.4 Casting of markings into the surface using round-edge
environmentally assisted cracking of titanium and its alloys should be
and round-bottom characters,
avoided.
6.5.5 Marking with vibrator-type contact,
5.2.2 Amethod such as one of the following for the removal 6.5.6 Electro-pencil marking, and
6.5.7 Marking with laser beam.
of adherent foreign material, if necessary.
5.2.2.1 Hot alkaline cleaner used as recommended. 6.6
...