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ASTM F1538

2003 Edition, April 10, 2003

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Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

Includes all amendments and changes through Reapproval Notice , 2017

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Product Details:

  • Revision: 2003 Edition, April 10, 2003
  • Published Date: January 2017
  • Status: Active, Most Current
  • Document Language: English
  • Published By: ASTM International (ASTM)
  • Page Count: 4
  • ANSI Approved: No
  • DoD Adopted: No

Description / 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.

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 mercurycontaining products, or both, in your state may be prohibited by state law.

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2 The boldface numbers in parentheses refer to the list of references at the end of this specification.