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ASTM F 1581 Document Information:
Title
Standard Specification for Composition of Anorganic Bone for Surgical Implants
ASTM International
Publication Date:
Feb 1, 2008
Scope:
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).
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).
This specification specifically excludes synthetic
hydroxylapatite, hydroxylapatite coatings, ceramic glasses,
tribasic calcium phosphate, whitlockite, and alpha- and
beta-tricalcium phosphate.
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.
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).
2 The boldface numbers in parentheses refer to the
list of references at the end of this specification.
Keywords:
- allogeneic
- anorganic
- apatite
- bone
- hydroxyapatite
- hydroxylapatite
- implant
- xenogeneic
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