ASTM F1538-03(2009)
(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
D
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.
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Designation:F1538 −03 (Reapproved 2009)
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 Apparent Porosity, andApparent Specific Gravity of Fired
Whiteware Products
1.1 This specification covers the material requirements and
C623 Test Method for Young’s Modulus, Shear Modulus,
characterization techniques for glass and glass-ceramic bioma-
and Poisson’s Ratio for Glass and Glass-Ceramics by
terials intended for use as bulk porous or powdered surgical
Resonance
implants, or as coatings on surgical devices, but not including
C633 Test Method for Adhesion or Cohesion Strength of
drug delivery systems.
Thermal Spray Coatings
1.2 The biological response to glass and glass-ceramic
C693 Test Method for Density of Glass by Buoyancy
biomaterials in bone and soft tissue has been demonstrated in
C729 Test Method for Density of Glass by the Sink-Float
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clinical use (1-12) and laboratory studies (13-17).
Comparator
1.3 This specification excludes synthetic hydroxylapatite, C730 Test Method for Knoop Indentation Hardness of Glass
C958 Test Method for Particle Size Distribution ofAlumina
hydroxylapatitecoatings,aluminumoxideceramics,alpha-and
beta-tricalcium phosphate, and whitlockite. or Quartz by X-Ray Monitoring of Gravity Sedimentation
C1069 Test Method for Specific SurfaceArea ofAlumina or
1.4 Warning—Mercury has been designated by EPA and
Quartz by Nitrogen Adsorption
many state agencies as a hazardous material that can cause
C1070 Test Method for Determining Particle Size Distribu-
central nervous system, kidney, and liver damage. Mercury, or
tion of Alumina or Quartz by Laser Light Scattering
its vapor, may be hazardous to health and corrosive to
E228 Test Method for Linear Thermal Expansion of Solid
materials.Cautionshouldbetakenwhenhandlingmercuryand
Materials With a Push-Rod Dilatometer
mercury-containing products. See the applicable product Ma-
F748 PracticeforSelectingGenericBiologicalTestMethods
terial Safety Data Sheet (MSDS) for details and EPA’s website
for Materials and Devices
(http://www.epa.gov/mercury/faq.htm) for additional informa-
F981 Practice for Assessment of Compatibility of Biomate-
tion. Users should be aware that selling mercury or mercury-
rials for Surgical Implants with Respect to Effect of
containingproducts,orboth,inyourstatemaybeprohibitedby
Materials on Muscle and Bone
state law.
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2.2 Code of Federal Regulations:
Title 21, Part 820
2. Referenced Documents
5
2.3 United States Pharmacopoeia:
3
2.1 ASTM Standards:
Lead <252>
C158 Test Methods for Strength of Glass by Flexure (De-
Mercury <261>
termination of Modulus of Rupture)
Arsenic <211>
C169 Test Methods for Chemical Analysis of Soda-Lime
Heavy Metals <231> Method I
and Borosilicate Glass 6
2.4 U.S. Geological Survey Method:
C373 Test Method for Water Absorption, Bulk Density,
Cadmium
3. Terminology
1
This specification is under the jurisdiction of ASTM Committee F04 on
3.1 Definitions of Terms Specific to This Standard:
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.13 on Ceramic Materials.
4
Current edition approved April 1, 2009. Published April 2009. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
´1
approved in 1994. Last previous edition approved in 2003 as F1538 – 03 . DOI: 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
10.1520/F1538-03R09. www.access.gpo.gov.
2 5
The boldface numbers in parentheses refer to the list of references at the end of Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
this specification. MD 20852-1790, http://www.usp.org.
3 6
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Crock, J.G., Felichte, F.E., Briggs, P.H., “Determination of Elements in
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM National Bureau of Standards Geological Reference Materials SRM 278 Obsidian
Standards volume information, refer to the standard’s Document Summary page on and SRM 688 Basalt by Inductively Coupled Plasma-Atomic Emission
the ASTM website. Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335–340.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1538−03 (2009)
3.1.1 bioactive glass—an amorphous silicate-based solid 5.1.2 Flexural Strength—When used as bulk ma
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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.
Designation:F1538–94 Designation: F 1538 – 03 (Reapproved 2009)
Standard Specification for
1
Glass and Glass Ceramic Biomaterials for Implantation
This standard is issued under the fixed designation F 1538; 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
2
use (1-91-12) and laboratory studies 10-14. 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.
2. Referenced Documents
3
2.1 ASTM Standards:
C 158 Method for Flexural Testing of Glass (Determination of Modulus of Rupture) Test Methods for Strength of Glass by
Flexure (Determination of Modulus of Rupture)
C 169 Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
C 373 Test Method for WaterAbsorption, Bulk Density,Apparent Porosity, andApparent Specific Gravity of Fired Whiteware
Products
C 623 Test Method for Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Glass and Glass-Ceramics by Resonance
C 633 Test Method for Adhesion or CohesiveCohesion Strength of Flame-Sprayed Thermal Spray Coatings
C 693 Test Method for Density of Glass by Buoyancy
C 729 Test Method for Density of Glass by the Sink-Float Comparator
3
C 730 Test Method for Knoop Indentation Hardness of Glass
C958Method for Determination of Particle Size Distribution of Alumina or Quartz by X-Ray Monitoring of Gravity
3
Sedimentation Test Method for Knoop Indentation Hardness of Glass
C 958 Test Method for Particle Size Distribution of Alumina or Quartz by X-Ray Monitoring of Gravity Sedimentation
3
C 1069 Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
3
C1070Test Method for Determining Particle Size Distribution ofAlumina or Quartz by Laser Light Scattering Test Method for
Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
C 1070 Test Method for Determining Particle Size Distribution of Alumina or Quartz by Laser Light Scattering
E 228 Test Method for Linear Thermal Expansion of Solid Materials withWith a Vitreous Silica Push-Rod Dilatometer
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices Practice for Selecting Generic
Biological Test Methods for Materials and Devices
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
1
This specification is under the jurisdiction ofASTM Committee F-4 F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.13 on Ceramic Materials.
Current edition approved Dec. 15, 1994. Published February 1995.
´1
Current edition approved April 1, 2009. Published April 2009. Originally approved in 1994. Last previous edition approved in 2003 as F 1538 – 03 .
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 15.02.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.
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