ASTM F1538-94

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1538 – 94
Standard Specification for
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. Scope E 228 Test Method for Linear Thermal Expansion of Solid
Materials with a Vitreous Silica Dilatometer
1.1 This specification covers the material requirements and
F 748 Practice for Selecting Generic Biological Test Meth-
characterization techniques for glass and glass-ceramic bioma-
ods for Materials and Devices
terials intended for use as bulk porous or powdered surgical
2.2 Code of Federal Regulations:
implants, or as coatings on surgical devices, but not including
Title 21, Part 820
drug delivery systems.
2.3 United States Pharmacopoeia:
1.2 The biological response to glass and glass-ceramic
Lead <252>
biomaterials in bone and soft tissue has been demonstrated in
2 Mercury <261>
clinical use 1-9 and laboratory studies 10-14.
Arsenic <211>
2. Referenced Documents Heavy Metals <231> Method found in Annual Book of
ASTM Standards, vol 13.01.
2.1 ASTM Standards:
2.4 U.S. Geological Survey Method:
C 158 Method for Flexural Testing of Glass (Determination
(7) Cadmium
of Modulus of Rupture)
C 169 Method for Chemical Analysis of Soda-Lime and
3. Terminology
Borosilicate Glass
3.1 Definitions of Terms Specific to This Standard:
C 623 Test Method for Young’s Modulus, Shear Modulus,
3.1.1 bioactive glass—an amorphous solid that is not intrin-
and Poisson’s Ratio for Glass and Glass-Ceramics by
sically adhesive and that is capable of forming a cohesive bond
Resonance
with both hard and soft tissue when exposed to appropriate in
C 633 Test Method for Adhesion or Cohesive Strength of
vivo or in vitro environments, such as simulated body fluid or
Flame-Sprayed Coatings
tris-hydroxymethylaminomethane buffer, by developing a sur-
C 693 Test Method for Density of Glass by Buoyancy
face layer of hydroxycarbonate apatite by release of ionic
C 729 Test Method for Density of Glass by the Sink-Float
species from the bulk material.
Comparator
3.1.2 bioactive glass-ceramic—an amorphous-derived crys-
C 730 Test Method for Knoop Indentation Hardness of
talline solid that is not intrinsically adhesive and that is capable
Glass
of forming a cohesive bond with bone and soft tissue when
C 958 Method for Determination of Particle Size Distribu-
exposed to appropriate in vivo or in vitro environments, such
tion of Alumina or Quartz by X-Ray Monitoring of Gravity
3 as simulated body fluid or tris-hydroxymethylaminomethane
Sedimentation
buffer, by developing a surface layer of hydroxycarbonate
C 1069 Method for Specific Surface Area of Alumina or
3 apatite by release of ionic species from the bulk material.
Quartz by Nitrogen Adsorption
3.1.3 bulk material—intended to describe a unit material
C 1070 Test Method for Determining Particle Size Distri-
3 used as a load bearing implant.
bution of Alumina or Quartz by Laser Light Scattering
3.1.4 coating—intended to describe a surface layer that is
relatively thin compared to the overall dimensions of the
prosthetic part that has been coated.
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. Annual Book of ASTM Standards, Vols 03.01 and 14.02.
Current edition approved Dec. 15, 1994. Published February 1995. Annual Book of ASTM Standards, Vol 13.01.
2 7
The boldface numbers in parentheses refer to the list of references at the end of Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
this specification. Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
3 8
Annual Book of ASTM Standards, Vol 15.02. Available from United Stated Pharmacopia, 12601 Twinbrook Parkway, Rock-
Annual Book of ASTM Standards, Vol 02.05. ville, MD 20852.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F1538–94
3.1.5 glass biomaterial—any one of a number of composi- except for special cases in which a reliable basis for conversion
tions of amorphous inorganic solids that are used as implant has been obtained by conversion tests.
materials for various medical or dental uses, or both. 5.1.5 Surface Area—The surface area of a particulate may
3.1.6 glass-ceramic biomaterials—any one of a number of be important in determining the reliability of the bioactivity of
compositions of an amorphous-derived crystalline solid that is the material. Whenever the specific surface area of the material
used as an implantable biomaterial for medical or dental use, or relates to function, the surface area of particulate glass and
both. glass ceramic biomaterials shall be measured using Method
3.1.7 particulate material—intended to describe several C 1069.
pieces (usually small size) used together within an implant 5.1.6 Bond Strength of Glass or Glass Ceramic Coating—
construct. When used as a coating on a metallic or ceramic substrate, the
bond strength of the coating shall be measured following Test
4. Chemical Requirements
Method C 633.
4.1 Bulk compositions shall be tested using Method C 169. 5.1.7 Crystallinity—For glass-ceramic biomaterials, the
4.2 The concentration of heavy metals in the bioactive glass percent crystallinity and crystal phases present in glass ceramic
and glass-ceramics shall be limited as follows: biomaterials shall be determined by means of X-ray diffraction
analysis. While there is no single standard method for deter-
Element ppm, max
As 3
mining the crystallinity and crystal phases of glass ceramic
Cd 5
materials, techniques such as those detailed in reference 10.16
Hg 5
and 10.17 should be followed to standardize methods as much
Pb 30
total heavy metals (as lead) 50
as possible.
5.1.8 Thermal Expansion—Thermal expansion shall be
For referee purposes, the methods listed in 2.2 and 2.3 shall
measured using Test Method E 228, when materials are to be
be used.
used for coatings (raw materials are to be measured), or on
5. Physical Characterization
finished product as a quality control test.
5.1 The following physical and mechanical characteriza-
6. Biocompatibility
tions may be applicable to various bioactive glass and glass-
6.1 Glass and glass-ceramic biomaterials should be evalu-
ceramics products and should be used whenever possible to
ated thoroughly for biocompatibility before human use. Bio-
verify the material.
active glass and glass-ceramic materials are unique in their
5.1.1 Density—The densities of glass and glass ceramic
mode of action when implanted in the body due to the released
materials are related directly to the processing history and
ionic species and the mechanisms by which these materials
composition of the material. The density of the bulk material
bond with bony tissue. These materials have been found to
shall be measured using Test Method C 729 and shall be
exhibit an excellent tissue response in laboratory studies 10-14
consistent for the specific materials.
and clinical usage 1-7. Before any new formulations are used
NOTE 1—This test should use a non-aqueous liquid for bioactive glass
clinically, the tissue response should be characterized by the
and glass ceramic materials, which are known to react in an aqueous
methods recommended in Practice F 748.
environment and could thereby affect the measurement.
7. Test Specimen Fabrication
5.
...