ASTM F1538-03(2009)
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
- Standard No.
- ASTM F1538-03(2009)
- Release Date
- 2003
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F1538-03(2017)
- Latest
- ASTM F1538-24
- 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.
ASTM F1538-03(2009) Referenced Document
- ASTM C1069 Standard Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
- ASTM C1070 Standard Test Method for Determining Particle Size Distribution of Alumina or Quartz by Laser Light Scattering
- ASTM C158 Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
- ASTM C169 Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
- ASTM C373 Standard Test Method for Water Absorption, Bulk Density, Apparent Porosity, and Apparent Specific Gravity of Fired Whiteware Products
- ASTM C623 Standard Test Method for Young's Modulus, Shear Modulus, and Poisson's Ratio for Glass and Glass-Ceramics by Resonance
- ASTM C633 Standard Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings
- ASTM C693 Standard Test Method for Density of Glass by Buoyancy
- ASTM C729 Standard Test Method for Density of Glass by the Sink-Float Comparator
- ASTM C730 Standard Test Method for Knoop Indentation Hardness of Glass
- ASTM C958 Standard Test Method for Particle Size Distribution of Alumina or Quartz by X-Ray Monitoring of Gravity Sedimentation
- ASTM E228 Standard Test Method for Linear Thermal Expansion of Solid Materials With a Vitreous Silica Dilatometer
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
ASTM F1538-03(2009) history
- 2024 ASTM F1538-24 Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation
- 2017 ASTM F1538-03(2017) Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
- 2003 ASTM F1538-03(2009) Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
- 2003 ASTM F1538-03e1 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
- 2003 ASTM F1538-03 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
- 1994 ASTM F1538-94 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
