ASTM F1538-03 - 10.4.2003
 
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)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.

 
2. Referenced Documents

C1070-01(2020)

Standard Test Method for Determining Particle Size Distribution of Alumina or Quartz by Laser Light Scattering

C1069-09(2022)

Standard Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption

Cadmium

Heavy Metals <231>

Method I

C693-93(2019)

Standard Test Method for Density of Glass by Buoyancy

C729-11(2022)

Standard Test Method for Density of Glass by the Sink-Float Comparator

C730-98(2021)

Standard Test Method for Knoop Indentation Hardness of Glass

C958-92(2022)

Standard Test Method for Particle Size Distribution of Alumina or Quartz by X-Ray Monitoring of Gravity Sedimentation

C623-21

Standard Test Method for Young's Modulus, Shear Modulus, and Poisson's Ratio for Glass and Glass-Ceramics by Resonance

C633-13(2021)

Standard Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings

C373-18(2023)

Standard 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

C169-16(2022)

Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass

C158-23

Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

E228-22

Standard Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod Dilatometer

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices