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ASTM F86-04

(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 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
30-Sep-2004
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
Current Stage
Ref Project

Relations

Replaces
ASTM F86-01 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
01-Oct-2004
Replaced By
ASTM F86-04(2009) - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Effective Date
01-Dec-2009
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Oct-2004
Referred By
ASTM F452-76(2022) - Standard Specification for Preformed Cranioplasty Plates
Effective Date
01-Oct-2004
Referred By
ASTM F3446-20 - Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
Effective Date
01-Oct-2004
Referred By
ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
Effective Date
01-Oct-2004
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
01-Oct-2004
Referred By
ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
Effective Date
01-Oct-2004
Referred By
ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Oct-2004
Referred By
ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
Effective Date
01-Oct-2004
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
01-Oct-2004
Referred By
ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Effective Date
01-Oct-2004
Referred By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
01-Oct-2004
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-Oct-2004
Referred By
ASTM F897-19 - Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Effective Date
01-Oct-2004

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ASTM F86-04 - Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsASTM F86-04 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
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ASTM F86-04 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information.
Designation:F86–04
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.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* 3.2 Ironparticles,ceramicmedia,andotherforeignparticles
may become smeared over or imbedded into the surface of
1.1 This practice provides a description of surface charac-
implants during processing operations such as forming, ma-
teristics, methods of surface preparation, and methods of
chining, tumbling, bead blasting, and so forth. These particles
marking for metallic surgical implants. Marking nomenclature
should be removed to minimize localized rust formation and
andneutralizationofendotoxinarenotspecifiedinthispractice
superficial blemishes.
(see X1.3). Surface requirements and marking methods in-
3.3 The various chemical and electrochemical surface treat-
cluded in the implant specification shall take precedence over
ments specified in this practice are intended to remove objec-
requirements listed in this practice, where appropriate.
tionable surface contaminants and to restore maximum corro-
1.2 This standard does not purport to address all of the
sion resistance to the passive oxide film.
safety concerns, if any, associated with its use. It is the
3.4 The need for an additional implant surface treatment
responsibility of the user of this standard to establish appro-
suchassecondarypassivationinnitricacidshouldbeevaluated
priate safety and health practices and determine the applica-
for localized implant surfaces that have electrochemical or
bility of regulatory limitations prior to use.
laser product markings created after the final surface treatment.
2. Referenced Documents
4. Description of Acceptable Surface Characteristics
2
2.1 ASTM Standards:
4.1 Metallic implants, when inspected in accordance with
A380 Practice for Cleaning, Descaling, and Passivation of
this practice, shall be free of surface imperfections such as
Stainless Steel Parts, Equipment, and Systems
toolmarks, nicks, scratches, cracks, cavities, burrs, and other
A967 Specification for Chemical Passivation Treatments
defects that would impair the serviceability of the device. The
for Stainless Steel Parts
surfaces shall be cleaned to minimize the presence of foreign
B600 Guide for Descaling and Cleaning Titanium and
material.
Titanium 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 a final surface treatment
according to Section 7.
3.1 The surface treatments documented in this practice are
intended to improve the corrosion resistance of metallic
5. Cleaning
surgicalimplantsmanufacturedfromiron,cobalt,titanium,and
5.1 Thesurfaceoftheimplantsshallbecleanedtominimize
tantalum base materials.
foreign material.
5.2 The cleaning operations used shall relate to the follow-
ing as appropriate:
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
5.2.1 A method such as organic solvent degreasing for the
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials. removal of oils, greases, and other loose surface contaminants.
Current edition approved Oct. 1, 2004. Published October 2004. Originally
NOTE 1—Anhydrous methanol and other solvents known to cause
approved in 1984. Last previous edition approved in 2001 as F86 – 01. DOI:
10.1520/F0086-04. environmentally assisted cracking of titanium and its alloys should be
2
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
5.2.2 Amethodsuchasoneofthefollowingfortheremoval
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. of adherent foreign material, if necessary.
*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 ----------------------
F86–04
5.2.2.1 Hot alkaline cleaner used as recommended. 6.5.6 Electro-pencil marking, and
5.2.2.2 Alkaline cleaner applied electrochemically as rec- 6.5.7 Marking with laser beam.
ommended. 6.6 Depending on the implant, its material, an
...

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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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Standard Specification and Test Methods for Metallic Medical Bone Screws

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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off