ASTM F1538-24
(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.
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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 − 24
Standard Specification for
1
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
3
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
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
C729 Test Method for Density of Glass by the Sink-Float
materials. Caution should be taken when handling mercury and
Comparator
mercury-containing products. See the applicable product Ma-
C730 Test Method for Knoop Indentation Hardness of Glass
terial Safety Data Sheet (MSDS) for details and EPA’s website
C958 Test Method for Particle Size Distribution of Alumina
(http://www.epa.gov/mercury/faq.htm) for additional informa-
or Quartz by X-Ray Monitoring of Gravity Sedimentation
tion. Users should be aware that selling mercury or mercury-
C1069 Test Method for Specific Surface Area of Alumina or
containing products, or both, in your state may be prohibited by
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 Muscle and Bone Tissue
Responses to Long-Term Implantable Materials Used in
1 Medical Devices
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 March 15, 2024. Published March 2024. Originally
3
approved in 1994. Last previous edition approved in 2017 as F1538 – 03 (2017). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/F1538-24. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
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
1
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F1538 − 24
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2.2 United States Pharmacopoeia: Either inductively coupled plasma/mass spectroscopy (ICP/
<252> Lead MS) (18), atomic absoprtion (AAS), or the methods listed in
<261> Mercury 2.2 and 2.3 shall be used.
<211> Arsenic
<231> Heavy Metals, Method I
5. Physical Characterization
5
2.3 U.S. Geological Survey Method:
5.1 The following physical and mechanical characteriza-
Cadmium
tions m
...
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 2017) F1538 − 24
Standard Specification for
Glass and Glass Ceramic Glass-Ceramic Biomaterials for
1
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
2
((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
3
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
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 May 1, 2017March 15, 2024. Published June 2017March 2024. Originally approved in 1994. Last previous edition approved in 20092017 as
F1538 – 03 (2009).(2017). DOI: 10.1520/F1538-03R17.10.1520/F1538-24.
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
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
1
---------------------- Page: 1 ----------------------
F1538 − 24
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 Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical
Devices
4
2.2 Code of Federal Regulations:
Title 21, Part 820
4
2.2 United States Pharmacopoeia:
Lead <252> Lead
Mercury <261> Mercury
Arse
...
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