ASTM F1538-03(2017)
(Specification)Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
ABSTRACT
This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. Glass and glass-ceramic biomaterials should be evaluated thoroughly for biocompatibility before human use. Tests shall be performed to determine the properties of the biomaterials, in accordance with the following test methods: bulk composition; density; flexural strength; Young's modulus; hardness; surface area; bond strength of glass or glass ceramic coating; crystallinity; thermal expansion; and particle size.
SCOPE
1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems.
1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-12)2 and laboratory studies (13-17).
1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite.
1.4 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.
1.5 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.
General Information
Relations
Buy Standard
Standards Content (Sample)
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.
Designation:F1538 −03 (Reapproved 2017)
Standard Specification for
Glass and Glass Ceramic Biomaterials for Implantation
This standard is issued under the fixed designation F1538; 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. Scope 2. Referenced Documents
1.1 This specification covers the material requirements and
2.1 ASTM Standards:
characterization techniques for glass and glass-ceramic bioma-
C158 Test Methods for Strength of Glass by Flexure (De-
terials intended for use as bulk porous or powdered surgical
termination of Modulus of Rupture)
implants, or as coatings on surgical devices, but not including
C169 Test Methods for Chemical Analysis of Soda-Lime
drug delivery systems.
and Borosilicate Glass
C373 Test Methods for Determination of Water Absorption
1.2 The biological response to glass and glass-ceramic
andAssociated Properties by Vacuum Method for Pressed
biomaterials in bone and soft tissue has been demonstrated in
Ceramic Tiles and Glass Tiles and Boil Method for
clinical use (1-12) and laboratory studies (13-17).
Extruded Ceramic Tiles and Non-tile Fired Ceramic
1.3 This specification excludes synthetic hydroxylapatite,
Whiteware Products
hydroxylapatitecoatings,aluminumoxideceramics,alpha-and
C623 Test Method for Young’s Modulus, Shear Modulus,
beta-tricalcium phosphate, and whitlockite.
and Poisson’s Ratio for Glass and Glass-Ceramics by
1.4 Warning—Mercury has been designated by EPA and
Resonance
many state agencies as a hazardous material that can cause
C633 Test Method for Adhesion or Cohesion Strength of
central nervous system, kidney, and liver damage. Mercury, or
Thermal Spray Coatings
its vapor, may be hazardous to health and corrosive to
C693 Test Method for Density of Glass by Buoyancy
materials.Cautionshouldbetakenwhenhandlingmercuryand
C729 Test Method for Density of Glass by the Sink-Float
mercury-containing products. See the applicable product Ma-
Comparator
terial Safety Data Sheet (MSDS) for details and EPA’s website
C730 Test Method for Knoop Indentation Hardness of Glass
(http://www.epa.gov/mercury/faq.htm) for additional informa-
C958 Test Method for Particle Size Distribution ofAlumina
tion. Users should be aware that selling mercury or mercury-
or Quartz by X-Ray Monitoring of Gravity Sedimentation
containingproducts,orboth,inyourstatemaybeprohibitedby
C1069 Test Method for Specific SurfaceArea ofAlumina or
state law.
Quartz by Nitrogen Adsorption
1.5 This international standard was developed in accor- C1070 Test Method for Determining Particle Size Distribu-
dance with internationally recognized principles on standard- tion of Alumina or Quartz by Laser Light Scattering
ization established in the Decision on Principles for the
E228 Test Method for Linear Thermal Expansion of Solid
Development of International Standards, Guides and Recom- Materials With a Push-Rod Dilatometer
mendations issued by the World Trade Organization Technical
F748 PracticeforSelectingGenericBiologicalTestMethods
Barriers to Trade (TBT) Committee.
for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
1 Materials on Muscle and Insertion into Bone
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 May 1, 2017. Published June 2017. Originally
approved in 1994. Last previous edition approved in 2009 as F1538 – 03 (2009). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/F1538-03R17. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this specification. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1538−03 (2017)
2.2 Code of Federal Regulations:
Element ppm, max
Arsenic (As) 3
Title 21, Part 820
Cadmium (Cd) 5
2.3 United States Pharmacopoeia: Mercury (Hg) 5
Lead (Pb) 30
Lead <252>
total heavy metals (as lead) 50
Mercury <261>
Either inductively-coupled plasma/mass spectroscopy (ICP/
Arsenic <211>
MS) (18), atomic absoprtion (AAS), or the methods listed in
Heavy Metals <231> Method I
2.3 and 2.4 shall be used.
2.4 U.S. Geological Survey Method:
Cadmium
5. Physical Characterization
5.1 The following physical and mechanical characteriza-
3. Terminology
tions may be applicable to various bioactive glass and glass-
3.1 Definitions of Terms Specific to This Standard:
ceramics products and should be used whenever possible to
3.1.1 bioactive glass—an amorphous silicate-based solid
verify the material.
that is not intrinsically adhesive and that is capable of forming
5.1.1 Density—The densities of glass and glass ceramic
acohesivebondwithbothhardandsofttissuewhenimplanted,
materials are related directly to the processing history and
and will develop a hydroxycarbonate apatite layer when
composition of the material. The density of the bulk material
exposed to appropriate in vitro environments, such as simu-
shall be measured using Test Methods C373 or C729 and shall
lated body fluid or tris-hydroxymethylaminomethane buffer.
be consistent for the specific materials.
3.1.2 bioactive glass-ceramic—an amorphous-derived crys-
NOTE 1—This test should use a non-aqueous liquid for bioactive glass
talline silicate-based solid that is not intrinsically adhesive and
and glass ceramic materials, which are known to react in an aqueous
that is capable of forming a cohesive bond with bone and soft
environment and could thereby affect the measurement.
tissue when implanted, and will develop a hydroxycarbonate
5.1.2 Flexural Strength—When used as bulk materials in
apatite layer when exposed to appropriate in vitro
load bearing applications, the flexural strength of the bulk
environments, such as simulated body fluid or tris-
material shall be measured using Test Methods C158.
hydroxymethylaminomethane buffer.
5.1.3 Young’s Modulus—When used as a bulk material,
3.1.3 bulk material—intended to describe a unit material
Young’s Modulus of glass and glass ceramic biomaterials shall
used as a load bearing implant.
be determined following Test Method C623.
3.1.4 coating—intended to describe a surface layer that is
5.1.4 Hardness—Where applicable, for characterization of
relatively thin compared to the overall dimensions of the
the material, the hardness of bulk samples shall be determined
prosthetic part that has been coated.
using Test Method C730. The Knoop indentation hardness is
3.1.5 glass biomaterial—any one of a number of composi-
one of many properties that is used to characterize glasses.
tions of amorphous inorganic solids that are used as implant
Attempts have been made to relate Knoop hardness to tensile
materials for various medical or dental uses, or both.
strength,butnogenerallyacceptedmethodsareavailable.Such
3.1.6 glass-ceramic biomaterials—any one of a number of
conversionislimitedinscopeandshouldbeusedwithcaution,
compositions of an amorphous-derived crystalline solid that is
exceptforspecialcasesinwhichareliablebasisforconversion
usedasanimplantablebiomaterialformedicalordentaluse,or
has been obtained by conversion tests.
both.
5.1.5 Surface Area—The surface area of a particulate may
3.1.7 particulate material—intended to describe several be important in determining the reliability of the bioactivity of
the material.Whenever the specific surface area of the material
pieces (usually small size) used together within an implant
construct. relates to function, the surface area of particulate glass and
glass ceramic biomaterials shall be measured using Test
4. Chemical Requirements Method C1069.
5.1.6 Bond Strength of Glass or Glass Ceramic Coating—
4.1 Bulk compositions shall be tested using Test Method
When used as a coating on a metallic or ceramic substrate, the
C169.
bond strength of the coating shall be measured following Test
4.2 The concentration of trace element levels in the bioac-
Method C633.
tive glass and glass-ceramics shall be limited as follows:
5.1.7 Crystallinity—For glass-ceramic biomaterials, the per-
cent crystallinity and crystal phases present in glass ceramic
biomaterials shall be determined by means of X-ray diffraction
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
analysis. While there is no single standard method for deter-
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
mining the crystallinity and crystal phases of glass ceramic
www.access.gpo.gov.
materials, techniques such as those detailed in Refs (19) and
Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
MD 20852-1790, http://www.usp.org. (20) should be followed to standardize methods as much as
Crock, J.G., Felichte, F.E., Briggs, P.H., “Determination of Elements in
possible
...
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: F1538 − 03 (Reapproved 2017)
Standard Specification for
Glass and Glass Ceramic Biomaterials for Implantation
This standard is issued under the fixed designation F1538; 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. Scope 2. Referenced Documents
1.1 This specification covers the material requirements and 2.1 ASTM Standards:
characterization techniques for glass and glass-ceramic bioma- C158 Test Methods for Strength of Glass by Flexure (De-
terials intended for use as bulk porous or powdered surgical termination of Modulus of Rupture)
implants, or as coatings on surgical devices, but not including C169 Test Methods for Chemical Analysis of Soda-Lime
drug delivery systems. and Borosilicate Glass
C373 Test Methods for Determination of Water Absorption
1.2 The biological response to glass and glass-ceramic
and Associated Properties by Vacuum Method for Pressed
biomaterials in bone and soft tissue has been demonstrated in
2 Ceramic Tiles and Glass Tiles and Boil Method for
clinical use (1-12) and laboratory studies (13-17).
Extruded Ceramic Tiles and Non-tile Fired Ceramic
1.3 This specification excludes synthetic hydroxylapatite,
Whiteware Products
hydroxylapatite coatings, aluminum oxide ceramics, alpha- and
C623 Test Method for Young’s Modulus, Shear Modulus,
beta-tricalcium phosphate, and whitlockite.
and Poisson’s Ratio for Glass and Glass-Ceramics by
1.4 Warning—Mercury has been designated by EPA and Resonance
C633 Test Method for Adhesion or Cohesion Strength of
many state agencies as a hazardous material that can cause
central nervous system, kidney, and liver damage. Mercury, or Thermal Spray Coatings
C693 Test Method for Density of Glass by Buoyancy
its vapor, may be hazardous to health and corrosive to
materials. Caution should be taken when handling mercury and C729 Test Method for Density of Glass by the Sink-Float
Comparator
mercury-containing products. See the applicable product Ma-
terial Safety Data Sheet (MSDS) for details and EPA’s website C730 Test Method for Knoop Indentation Hardness of Glass
(http://www.epa.gov/mercury/faq.htm) for additional informa- C958 Test Method for Particle Size Distribution of Alumina
or Quartz by X-Ray Monitoring of Gravity Sedimentation
tion. Users should be aware that selling mercury or mercury-
containing products, or both, in your state may be prohibited by C1069 Test Method for Specific Surface Area of Alumina or
Quartz by Nitrogen Adsorption
state law.
C1070 Test Method for Determining Particle Size Distribu-
1.5 This international standard was developed in accor-
tion of Alumina or Quartz by Laser Light Scattering
dance with internationally recognized principles on standard-
E228 Test Method for Linear Thermal Expansion of Solid
ization established in the Decision on Principles for the
Materials With a Push-Rod Dilatometer
Development of International Standards, Guides and Recom-
F748 Practice for Selecting Generic Biological Test Methods
mendations issued by the World Trade Organization Technical
for Materials and Devices
Barriers to Trade (TBT) Committee.
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
This specification is under the jurisdiction of ASTM Committee F04 on
Materials on Muscle and Insertion into Bone
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials.
Current edition approved May 1, 2017. Published June 2017. Originally
approved in 1994. Last previous edition approved in 2009 as F1538 – 03 (2009). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/F1538-03R17. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this specification. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1538 − 03 (2017)
2.2 Code of Federal Regulations:
Element ppm, max
Arsenic (As) 3
Title 21, Part 820
Cadmium (Cd) 5
2.3 United States Pharmacopoeia:
Mercury (Hg) 5
Lead (Pb) 30
Lead <252>
total heavy metals (as lead) 50
Mercury <261>
Either inductively-coupled plasma/mass spectroscopy (ICP/
Arsenic <211>
MS) (18), atomic absoprtion (AAS), or the methods listed in
Heavy Metals <231> Method I
2.3 and 2.4 shall be used.
2.4 U.S. Geological Survey Method:
Cadmium
5. Physical Characterization
5.1 The following physical and mechanical characteriza-
3. Terminology
tions may be applicable to various bioactive glass and glass-
3.1 Definitions of Terms Specific to This Standard:
ceramics products and should be used whenever possible to
3.1.1 bioactive glass—an amorphous silicate-based solid
verify the material.
that is not intrinsically adhesive and that is capable of forming
5.1.1 Density—The densities of glass and glass ceramic
a cohesive bond with both hard and soft tissue when implanted,
materials are related directly to the processing history and
and will develop a hydroxycarbonate apatite layer when
composition of the material. The density of the bulk material
exposed to appropriate in vitro environments, such as simu-
shall be measured using Test Methods C373 or C729 and shall
lated body fluid or tris-hydroxymethylaminomethane buffer.
be consistent for the specific materials.
3.1.2 bioactive glass-ceramic—an amorphous-derived crys-
NOTE 1—This test should use a non-aqueous liquid for bioactive glass
talline silicate-based solid that is not intrinsically adhesive and
and glass ceramic materials, which are known to react in an aqueous
that is capable of forming a cohesive bond with bone and soft
environment and could thereby affect the measurement.
tissue when implanted, and will develop a hydroxycarbonate
5.1.2 Flexural Strength—When used as bulk materials in
apatite layer when exposed to appropriate in vitro
load bearing applications, the flexural strength of the bulk
environments, such as simulated body fluid or tris-
material shall be measured using Test Methods C158.
hydroxymethylaminomethane buffer.
5.1.3 Young’s Modulus—When used as a bulk material,
3.1.3 bulk material—intended to describe a unit material
Young’s Modulus of glass and glass ceramic biomaterials shall
used as a load bearing implant.
be determined following Test Method C623.
3.1.4 coating—intended to describe a surface layer that is
5.1.4 Hardness—Where applicable, for characterization of
relatively thin compared to the overall dimensions of the
the material, the hardness of bulk samples shall be determined
prosthetic part that has been coated.
using Test Method C730. The Knoop indentation hardness is
3.1.5 glass biomaterial—any one of a number of composi-
one of many properties that is used to characterize glasses.
tions of amorphous inorganic solids that are used as implant
Attempts have been made to relate Knoop hardness to tensile
materials for various medical or dental uses, or both.
strength, but no generally accepted methods are available. Such
3.1.6 glass-ceramic biomaterials—any one of a number of
conversion is limited in scope and should be used with caution,
compositions of an amorphous-derived crystalline solid that is
except for special cases in which a reliable basis for conversion
used as an implantable biomaterial for medical or dental use, or
has been obtained by conversion tests.
both.
5.1.5 Surface Area—The surface area of a particulate may
be important in determining the reliability of the bioactivity of
3.1.7 particulate material—intended to describe several
pieces (usually small size) used together within an implant the material. Whenever the specific surface area of the material
relates to function, the surface area of particulate glass and
construct.
glass ceramic biomaterials shall be measured using Test
Method C1069.
4. Chemical Requirements
5.1.6 Bond Strength of Glass or Glass Ceramic Coating—
4.1 Bulk compositions shall be tested using Test Method
When used as a coating on a metallic or ceramic substrate, the
C169.
bond strength of the coating shall be measured following Test
4.2 The concentration of trace element levels in the bioac-
Method C633.
tive glass and glass-ceramics shall be limited as follows:
5.1.7 Crystallinity—For glass-ceramic biomaterials, the per-
cent crystallinity and crystal phases present in glass ceramic
biomaterials shall be determined by means of X-ray diffraction
Available from U.S. Government Printing Office Superintendent of Documents,
analysis. While there is no single standard method for deter-
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
mining the crystallinity and crystal phases of glass ceramic
www.access.gpo.gov.
5 materials, techniques such as those detailed in Refs (19) and
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
MD 20852-1790, http://www.usp.org. (20) should be followed to standardize methods as much as
Crock, J.G., Felichte, F.E., Briggs, P.H., “Determination of Elements in
possible.
National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
5.
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: F1538 − 03 (Reapproved 2009) F1538 − 03 (Reapproved 2017)
Standard Specification for
Glass and Glass Ceramic Biomaterials for Implantation
This standard is issued under the fixed designation F1538; 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. Scope
1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials
intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery
systems.
1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical
use (1-12) and laboratory studies (13-17).
1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and
beta-tricalcium phosphate, and whitlockite.
1.4 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.
1.5 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.
2. Referenced Documents
2.1 ASTM Standards:
C158 Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
C169 Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
C373 Test Methods for Determination of Water Absorption and Associated Properties by Vacuum Method for Pressed Ceramic
Tiles and Glass Tiles and Boil Method for Extruded Ceramic Tiles and Non-tile Fired Ceramic Whiteware Products
C623 Test Method for Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Glass and Glass-Ceramics by Resonance
C633 Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings
C693 Test Method for Density of Glass by Buoyancy
C729 Test Method for Density of Glass by the Sink-Float Comparator
C730 Test Method for Knoop Indentation Hardness of Glass
C958 Test Method for Particle Size Distribution of Alumina or Quartz by X-Ray Monitoring of Gravity Sedimentation
C1069 Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
C1070 Test Method for Determining Particle Size Distribution of Alumina or Quartz by Laser Light Scattering
E228 Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod Dilatometer
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
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 April 1, 2009May 1, 2017. Published April 2009June 2017. Originally approved in 1994. Last previous edition approved in 20032009 as
ε1
F1538 – 03 (2009). . DOI: 10.1520/F1538-03R09.10.1520/F1538-03R17.
The boldface numbers in parentheses refer to the list of references at the end of this specification.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1538 − 03 (2017)
2.2 Code of Federal Regulations:
Title 21, Part 820
2.3 United States Pharmacopoeia:
Lead <252>
Mercury <261>
Arsenic <211>
Heavy Metals <231> Method I
2.4 U.S. Geological Survey Method:
Cadmium
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bioactive glass—an amorphous silicate-based solid that is not intrinsically adhesive and that is capable of forming a
cohesive bond with both hard and soft tissue when implanted, and will develop a hydroxycarbonate apatite layer when exposed
to appropriate in vitro environments, such as simulated body fluid or tris-hydroxymethylaminomethane buffer.
3.1.2 bioactive glass-ceramic—an amorphous-derived crystalline silicate-based solid that is not intrinsically adhesive and that
is capable of forming a cohesive bond with bone and soft tissue when implanted, and will develop a hydroxycarbonate apatite layer
when exposed to appropriate in vitro environments, such as simulated body fluid or tris-hydroxymethylaminomethane buffer.
3.1.3 bulk material—intended to describe a unit material used as a load bearing implant.
3.1.4 coating—intended to describe a surface layer that is relatively thin compared to the overall dimensions of the prosthetic
part that has been coated.
3.1.5 glass biomaterial—any one of a number of compositions of amorphous inorganic solids that are used as implant materials
for various medical or dental uses, or both.
3.1.6 glass-ceramic biomaterials—any one of a number of compositions of an amorphous-derived crystalline solid that is used
as an implantable biomaterial for medical or dental use, or both.
3.1.7 particulate material—intended to describe several pieces (usually small size) used together within an implant construct.
4. Chemical Requirements
4.1 Bulk compositions shall be tested using Test Method C169.
4.2 The concentration of trace element levels in the bioactive glass and glass-ceramics shall be limited as follows:
Element ppm, max
Arsenic (As) 3
Cadmium (Cd) 5
Mercury (Hg) 5
Lead (Pb) 30
total heavy metals (as lead) 50
Either inductively-coupled plasma/mass spectroscopy (ICP/MS) (18), atomic absoprtion (AAS), or the methods listed in 2.3 and
2.4 shall be used.
5. Physical Characterization
5.1 The following physical and mechanical characterizations may be applicable to various bioactive glass and glass-ceramics
products and should be used whenever possible to verify the material.
5.1.1 Density—The densities of glass and glass ceramic materials are related directly to the processing history and composition
of the material. The density of the bulk material shall be measured using Test Methods C373 or C729 and shall be consistent for
the specific materials.
NOTE 1—This test should use a non-aqueous liquid for bioactive glass and glass ceramic materials, which are known to react in an aqueous environment
and could thereby affect the measurement.
5.1.2 Flexural Strength—When used as bulk materials in load bearing applications, the flexural strength of the bulk material
shall be measured using Test Methods C158.
5.1.3 Young’s Modulus—When used as a bulk material, Young’s Modulus of glass and glass ceramic biomaterials shall be
determined following Test Method C623.
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Crock, J.G., Felichte, F.E., Briggs, P.H., “Determination of Elements in National Bureau of Standards Geological Reference Materials SRM 278 Obsidian and SRM 688
Basalt by Inductively Coupled Plasma-Atomic Emission Spectrometry,” Geostandards NewsletterVol 7, 1983pp. 335–340.
F1538 − 03 (2017)
5.1.4 Hardness—Where applicable, for characterization of the material, the hardness of bulk samples shall be determined using
Test Method C730. The Knoop indentation hardness is one of many properties that is used to characterize glasses. Attempts have
been made to relate Knoop hardness to tensile strength, but no generally accepted methods are available. Such conversion is limited
in scope and should be used with caution, except for special cases in which a reliable basis for conversion has been obtained by
conversion tests.
5.1.5 Surface Area—The surface area of a particulate may be important in determining the reliability of the bioactivity of the
material. Whenever the specific surface area of the material relates to function, the surface area of particulate glass and glass
ceramic biomaterials shall be measured using Test Method C1069.
5.1.6 Bond Strength of Glass or Glass Ceramic Coating—When used as a coating on a metallic or ceramic substrate, the bond
strength of the coating shall be measured following Test Method C633.
5.1.7 Crystallinity—For glass-ceramic biomaterials, the percent crystallinity and crystal phases present in glass ceramic
biomaterials s
...
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