Norm

ASTM F1538-03(2009)

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

48,24

Over deze norm

Status Definitief
Aantal pagina's 4
Commissie F04.13
Gepubliceerd op 01-04-2009
Taal Engels
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.

Details

ICS-code 11.040.40
Nederlandse titel Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
Engelse titel Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

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