Standard Historical Last Updated: Jul 03, 2017 Track Document
ASTM F1538-03(2009)

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation F1538-03R09 ASTM|F1538-03R09|en-US Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation Standard new BOS Vol. 13.01 Committee F04
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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

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 WarningMercury 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 EPAs 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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.13
Pages: 4
DOI: 10.1520/F1538-03R09
ICS Code: 11.040.40