Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
STANDARD published on 15.4.2023
Designation standards: ASTM F1185-23
Publication date standards: 15.4.2023
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM
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.
Keywords:
bioceramic, bone graft, hydroxylapatite (HA), hydroxyapatite, tricalcium phosphate (TCP), whitlockite,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)