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ASTM F 2224 Document Information:
Title
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
ASTM International
Publication Date:
Jan 10, 2003
Scope:
This specification covers material requirements for unfabricated and
fabricated forms of hydrated
calcium sulfate intended for surgical implants. Fabricated forms may
include pressed and cast
surgical implants in various geometric shapes. The calcium sulfate
hemihydrate in the unfabricated
form can be converted with the addition of water or other
water-containing solutions to a
fabricated calcium sulfate dihydrate form.
The requirements of this specification apply to calcium sulfate
combined with two molecules of
water or two calcium sulfate molecules sharing one water molecule.
Approximate chemical formulae:
This specification specifically excludes calcium sulfate anhydrite and
calcium sulfate forms that
contain additives such as reinforcing phases, medicaments, biological
agents, and so forth.
The presence of processing aids does not exclude a product from the
physical and mechanical
requirements of this specification.
Some provisions of Specification C 59/C 59M and Test Methods C 472
apply. Special requirements that
are detailed in this specification are included to characterize the
material which will be used in
surgical implants.
The biological response to calcium sulfate in bone tissue has been
well characterized by a history
of clinical use (1-14) and by laboratory studies (15-18).
The following precautionary caveat pertains only to the test method
portion, Sections 4, 5, and 6,
of this specification. This standard does not purport to address all
of the safety concerns, if
any, 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 requirements
prior to use.
Keywords:
- bone
- calcium sulfate
- gypsum
- implant
- plaster
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