ASTM F 1538 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
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ASTM F 1538 Document Information:
Title
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
ASTM International
Publication Date:
Apr 10, 2003
Scope:
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.
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).
This specification excludes synthetic hydroxylapatite,
hydroxylapatite coatings, aluminum oxide ceramics, alpha- and
beta-tricalcium phosphate, and whitlockite.
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 The boldface numbers in parentheses refer to the
list of references at the end of this specification.
Keywords:
- bioactive glass
- bioactive glass-ceramics
- glass biomaterials
- glass-ceramics biomaterial
- surgical implants
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