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ASTM F 1185 Document Information:
Title
Standard Specification for Composition of Hydroxylapatite for Surgical Implants
ASTM International
Publication Date:
Apr 10, 2003
Scope:
This specification covers chemical and crystallographic
requirements for hydroxylapatite intended for surgical implants.
For a material to be called hydroxylapatite, it must conform to
this specification. (See Appendix X1.)
The biological response to hydroxylapatite in soft tissue and
bone has been characterized by a history of clinical use
(1-3)2 and by laboratory studies
(4-6).
This specification includes powder, particulate, and forms
intended for use as surgical implants, components of surgical
implants, or as raw materials for manufacturing processes such as
thermal spray coating, electrophoretic deposition, physical vapor
deposition, and so forth.
This specification specifically excludes hydroxylapatite
coatings, amorphous calcium phosphate, ceramic-glasses, tribasic
calcium phosphate, whitlockite, and alpha- and betatricalcium
phosphate. (See Specification F 1088.)
The values stated in SI units are to be regarded as standard. No
other units of measurement are included in this standard.
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
limitations prior to use.
2 The boldface numbers in parentheses refer to the
list of references at the end of this specification.
Keywords:
- bioceramic
- bone graft
- hydroxylapatite (HA)
- hydroxyapatite
- tricalcium phosphate (TCP)
- whitlockite
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