ASTM F1538-03e1

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) 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.

General Information

• Status: Historical
• Publication Date: 09-Apr-2003
• 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

Relations

• Replaces: ASTM F1538-03 - Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
• Effective Date: 10-Apr-2003
• Replaced By: ASTM F1538-03(2009) - Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
• Effective Date: 01-Apr-2009
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Apr-2003

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
e1
Designation: F 1538 – 03
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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Mercury warning was editorially added in April 2008.
1. Scope and Borosilicate Glass
C 373 Test Method for Water Absorption, Bulk Density,
1.1 This specification covers the material requirements and
Apparent Porosity, andApparent Specific Gravity of Fired
characterization techniques for glass and glass-ceramic bioma-
Whiteware Products
terials intended for use as bulk porous or powdered surgical
C 623 Test Method for Young’s Modulus, Shear Modulus,
implants, or as coatings on surgical devices, but not including
and Poisson’s Ratio for Glass and Glass-Ceramics by
drug delivery systems.
Resonance
1.2 The biological response to glass and glass-ceramic
C 633 Test Method for Adhesion or Cohesive Strength of
biomaterials in bone and soft tissue has been demonstrated in
2
Thermal Sprayed Coatings
clinical use (1-12) and laboratory studies (13-17).
C 693 Test Method for Density of Glass by Buoyancy
1.3 This specification excludes synthetic hydroxylapatite,
C 729 Test Method for Density of Glass by the Sink-Float
hydroxylapatitecoatings,aluminumoxideceramics,alpha-and
Comparator
beta-tricalcium phosphate, and whitlockite.
C 730 Test Method for Knoop Indentation Hardness of
1.4 Warning—Mercury has been designated by EPA and
Glass
many state agencies as a hazardous material that can cause
C 958 Test Method for Particle Size Distribution of Alu-
central nervous system, kidney, and liver damage. Mercury, or
mina or Quartz by X-Ray Monitoring of Gravity Sedimen-
its vapor, may be hazardous to health and corrosive to
tation
materials.Cautionshouldbetakenwhenhandlingmercuryand
C 1069 Test Method for Specific Surface Area of Alumina
mercury-containing products. See the applicable product Ma-
or Quartz by Nitrogen Adsorption
terial Safety Data Sheet (MSDS) for details and EPA’s website
C 1070 Test Method for Determining Particle Size Distri-
(http://www.epa.gov/mercury/faq.htm) for additional informa-
bution of Alumina or Quartz by Laser Light Scattering
tion. Users should be aware that selling mercury or mercury-
E 228 Test Method for Linear Thermal Expansion of Solid
containingproducts,orboth,inyourstatemaybeprohibitedby
Materials with a Vitreous Silica Dilatometer
state law.
F 748 Practice for Selecting Generic Biological Test Meth-
2. Referenced Documents ods for Materials and Devices
3
F 981 Practice for Assessment of Compatibility of Bioma-
2.1 ASTM Standards:
terials for Surgical Implants with Respect to Effect of
C 158 Test Methods for Strength of Glass by Flexure
Materials on Muscle and Bone
(Determination of Modulus of Rupture)
4
2.2 Code of Federal Regulations:
C 169 Test Method for Chemical Analysis of Soda-Lime
Title 21, Part 820
5
2.3 United States Pharmacopoeia:
1
This specification is under the jurisdiction of ASTM Committee F04 on
Lead <252>
Medical and Surgical Materials and Devices and is the direct responsibility of
Mercury <261>
Subcommittee F04.13 on Ceramic Materials.
Arsenic <211>
Current edition approved April 10, 2003. Published May 2003. Originally
approved in 1994. Last previous edition approved in 1994 as F 1538 – 94. Heavy Metals <231> Method I
2
The boldface numbers in parentheses refer to the list of references at the end of
this specification.
3 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from U.S. Government Printing Office, Superintendent of Docu-
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM ments, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
5
Standards volume information, refer to the standard’s Document Summary page on Available from United Stated Pharmacopia, 12601 Twinbrook Parkway, Rock-
the ASTM website. ville, MD 20852.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F1538–03
6
2.4 U.S. Geological Survey Method: 5.1.1 Density—The densities of glass and glass ceramic
Cadmium materials are related directly to the processing history and
composition of the material. The density of the bulk material
3. Terminology
shallbemeasuredusingTestMethodsC 373orC 729andshall
be consistent for the specific materials.
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bioactive glass—an amorphous silicate-based solid
NOTE 1—This test should use a non-aque
...

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:F1538–94 Designation: F 1538 – 03
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 (e) 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 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 158Method 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 Method for Chemical Analysis of Soda-Lime and Borosilicate Glass
3
C623Test Method for Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Glass and Glass-Ceramics by Resonance
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 Cohesive Strength of Flame-Sprayed Thermal Sprayed 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 730Test 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 1069Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
3
C1070Test Method for Determining Particle Size Distribution of Alumina 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 with a Vitreous Silica Dilatometer
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
1
This specification is under the jurisdiction of ASTM Committee F-4 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
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 10, 2003. Published May 2003. Originally approved in 1994. Last previous edition approved in 1994 as F 1538 – 94.
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 [e-mail]. 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 Internat
...