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ASTM F1609-08

(Specification)

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

ABSTRACT
This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization. This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: mechanical capture, plasma spray deposition, dipping/sintering, electrophoretic deposition, porcelainizing, and sputtering. Substrates may include smooth, porous, textured, and other implantable topographical forms. This specification excludes organic coatings that may contain calcium and phosphate ionic species. Materials shall be tested and the individual grades shall conform to chemical requirements such as elemental analysis for calcium and phosphates, and intentional additions, trace element analysis for hydroxylapatite and beta tricalcium phosphate; crystallographic characterization such as Fourier Transform infrared spectroscopy, and environmental stability; physical characterization such as coverage of substrate, thickness, porosity, color, surface topography, and density; and mechanical characterization such as tensile bond strength, shear strength, and fatigue strength. The test specimen fabrication and contact with calcium phosphate coatings are also detailed.
SCOPE
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.
1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2) and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.
1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: (1) mechanical capture, (2) plasma spray deposition, (3) dipping/sintering, (4) electrophoretic deposition, (5) porcelainizing, and (6) sputtering.
1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms.
1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species.
1.6 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

General Information

Status
Historical
Publication Date
30-Apr-2008
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.13 - Ceramic Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F1609-03e1 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Effective Date
01-May-2008
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-May-2008

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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:F1609 −08
StandardSpecification for
1
Calcium Phosphate Coatings for Implantable Materials
This standard is issued under the fixed designation F1609; 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.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
4
1.1 This specification covers the material requirements for
2.1 ASTM Standards:
calcium phosphate coatings for surgical implant applications. E376 Practice for Measuring Coating Thickness by
Magnetic-Field or Eddy-Current (Electromagnetic) Test-
1.2 In particulate and monolithic form, the calcium phos-
ing Methods
phate materials system has been well-characterized regarding
2 F1044Test Method for Shear Testing of Calcium Phosphate
biological response (1,2) and laboratory characterization (2-
Coatings and Metallic Coatings
4). Several publications (5-10) have documented the in vitro
F1088Specification for Beta-Tricalcium Phosphate for Sur-
and in vivo properties of selected calcium phosphate coating
gical Implantation
systems.
F1147Test Method for Tension Testing of Calcium Phos-
1.3 This specification includes hydroxylapatite coatings,
phate and Metallic Coatings
tricalciumphosphatecoatings,orcombinationsthereof,withor
F1160Test Method for Shear and Bending Fatigue Testing
without intentional minor additions of other ceramic or
ofCalciumPhosphateandMetallicMedicalandCompos-
3
metallic, andappliedbymethodsincluding,butnotlimitedto,
ite Calcium Phosphate/Metallic Coatings
the following: (1) mechanical capture, (2) plasma spray
F1185Specification for Composition of Hydroxylapatite for
deposition, (3) dipping/sintering, (4) electrophoretic
Surgical Implants
deposition, (5) porcelainizing, and (6) sputtering.
F1854Test Method for Stereological Evaluation of Porous
1.4 Substrates may include smooth, porous, textured, and Coatings on Medical Implants
other implantable topographical forms.
F1926Test Method for Evaluation of the Environmental
Stability of Calcium Phosphate Coatings
1.5 This specification excludes organic coatings that may
F2024PracticeforX-rayDiffractionDeterminationofPhase
contain calcium and phosphate ionic species.
Content of Plasma-Sprayed Hydroxyapatite Coatings
1.6 Warning—Mercury has been designated by EPA and 5
2.2 Pharmacopeia Convention Documents:
many state agencies as a hazardous material that can cause
National Formulary XVI,Tribasic Calcium Phosphate
central nervous system, kidney, and liver damage. Mercury, or
United States Pharmacopeia:
its vapor, may be hazardous to health and corrosive to
U.S. Pharmacopeia (most current),ChemicalTests:Calcium
materials.Cautionshouldbetakenwhenhandlingmercuryand
(191), Phosphorous (191), Lead <251>, Mercury <261>,
mercury-containing products. See the applicable product Ma-
Arsenic < 211>, and Heavy Metals <231> Method (1)
terial Safety Data Sheet (MSDS) for details and EPA’s website
2.3 Other Documents:
(http://www.epa.gov/mercury/faq.htm) for additional informa-
6
U.S. Geological Survey Method,Cadmium
tion. Users should be aware that selling mercury or mercury-
U.S. Code of Federal Regulations Title 21 (CFR 21), Part
containingproducts,orboth,inyourstatemaybeprohibitedby
7
820–Quality System Regulation
state law. 3
X-Ray DiffractionAnalyses
1
This specification is under the jurisdiction of ASTM Committee F04 on
4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved May 1, 2008. Published June 2008. Originally Standards volume information, refer to the standard’s Document Summary page on
´1
approved in 1995. Last previous edition approved in 2003 as F1609–03 . DOI: the ASTM website.
5
10.1520/F1609-08. AvailablefromU.S.Pharmacopeia(USP),12601TwinbrookPkwy.,Rockville,
2
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof MD 20852-1790, http://www.usp.org.
6
this specification. Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in
3
The Joint Committee on Powdered Diffraction has established a Powder National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
Diffraction File. The committee operates on an international basis and cooperates and SRM 688 Basalt by Inductively Coupled Argon Plasma—Atomic Emission
closely with the Data Commission of the International Union of Crystallinity and Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335–340.
7
ASTM. Hydroxylapatite data can be found on file card No. 9-432; bet
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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.
e1
Designation:F1609–03 Designation: F 1609 – 08
Standard Specification for
1
Calcium Phosphate Coatings for Implantable Materials
This standard is issued under the fixed designation F 1609; 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.
1
e NOTE—Mercury warning was editorially added in April 2008.
1. Scope
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.
1.2 Inparticulateandmonolithicform,thecalciumphosphatematerialssystemhasbeenwell-characterizedregardingbiological
2
response (1,2) and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo
properties of selected calcium phosphate coating systems.
1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or
3
without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the
following: ( 1) mechanical capture, (2) plasma spray deposition, (3) dipping/sintering, (4) electrophoretic deposition, (5)
porcelainizing, and (6) sputtering.
1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms.
1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species.
1.6 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central
nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution
should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet
(MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware
that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
2. Referenced Documents
4
2.1 ASTM Standards:
E 376 Practice for Measuring Coating Thickness by Magnetic-Field or Eddy-Current (Electromagnetic) TestExamination
Methods
F 1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F 1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F 1147 Test Method for Tension Testing of Calcium Phosphate Coatings and Metallic Coatings
F 1160 TestMethodforShearandBendingFatigueTestingofCalciumPhosphateandMetallisMetallicMedicalandComposite
Calcium Phosphate/Metallic Coatings
F 1185 Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
F 1854Shear and Bending Fatigue Testing of Calcium Phosphate and Metallis Medical and Composite Calcium Phosphate
Metallic Coatings Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F 1926 Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
F 2024 Practice for X-RayX-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxylapatite Coatings
5
2.2 Pharmacopeia Convention Documents:
National Formulary XVI, Tribasic Calcium Phosphate
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved Sept. 10, 2003. Published October 2003. Originally approved in 1995. Last previous edition approved in 1995 as F1609–95.
´1
Current edition approved May 1, 2008. Published June 2008. Originally approved in 1995. Last previous edition approved in 2003 as F 1609 – 03 .
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
The Joint Committee on Powdered Diffraction has established a Powder Diffraction File. The committee operates on an international basis and cooperates closely with
the Data Commission of the International Union of Crystallinity and ASTM. Hydroxylapatite data can be found on file card No. 9-432; beta tricalcium phosphate data can
be found on file card No. 9-169.
4
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
5
Availa
...

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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
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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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
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.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
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.

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