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ASTM International - ASTM F1581-08(2016)

Standard Specification for Composition of Anorganic Bone for Surgical Implants

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Organization: ASTM International
Publication Date: 1 October 2016
Status: inactive
Page Count: 4
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1).

1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7).

1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 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 Safety Data Sheet (DS) 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.

1.6 This standard does not purport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).

abstract:

This specification covers material requirements for chemical composition of anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. This specification specifically... View More

Document History

August 1, 2020
Standard Specification for Composition of Anorganic Bone for Surgical Implants
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone,...
ASTM F1581-08(2016)
October 1, 2016
Standard Specification for Composition of Anorganic Bone for Surgical Implants
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone,...
October 1, 2012
Standard Specification for Composition of Anorganic Bone for Surgical Implants
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone,...
February 1, 2008
Standard Specification for Composition of Anorganic Bone for Surgical Implants
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone,...
February 1, 2008
Standard Specification for Composition of Anorganic Bone for Surgical Implants
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone,...
February 10, 1999
Standard Specification for Composition of Anorganic Bone for Surgical Implants
1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (hydroxylapatite) intended for surgical implants. For a material to be called anorganic or deorganified...
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