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ASTM-F1538:2003 Edition

ASTM-F1538:2003 Edition

$35.75

F1538-03e1 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

Published By Publication Date Number of Pages
ASTM 2003 4
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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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
2 Terminology
Chemical Requirements
Physical Characterization
Biocompatibility
3 Test Specimen Fabrication
Quality Program Requirement
Keywords
X1. RATIONALE
X1.1
X1.2
X1.3
X1.4
TABLE X1.1
4 X2. BIOCOMPATIBILITY
X2.1
REFERENCES

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