ASTM F1185

This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of hydroxylapatite. The calcium and phosphorus contents shall be determined using a suitable method such as ion chromatography. A quantitative X-ray diffraction analysis shall indicate a minimum hydroxylapatite content of 95 %. The concentration of trace elements such as arsenic, cadmium, mercury, and lead shall be determined for hydroxylapatite derived from natural resources. The analysis of other trace elements may be required, based on the conditions, apparatus, or environments specific to the manufacturing techniques and raw materials. Either inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods mentioned shall be used.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

1. Scope

1.1 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.)

1.2 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).

1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacutring processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth.

1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088.)

2. Referenced Documents

F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F2024 Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Arsenic 211>
C1 Specification of General Requirements for a Quality Program
Cadmium
Heavy Metals 231> Method 1
Identification Tests for Calcium and Phosphate 191>
Lead 251>
Mercury 261>
Title 21, Part 820.
Tribasic Calcium Phosphate

Index Terms

bioceramic; bone graft; hydroxylapatite (HA); hydroxyapatite; tricalcium phosphate (TCP); whitlockite; ICS Number Code 11.040.40

Citing ASTM Standards

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