Would you like to analyze the hydroxylapatite in your medical devices according to ASTM F1609-23?
What does ASTM F1609-23 specify?
ASTM F1609-23 is a technical specification detailing the requirements for calcium phosphate coatings used in surgical implant applications, particularly their composition, application methods, and physical and mechanical properties. It covers both particulate and monolithic forms of calcium phosphate materials. The coating types included in this specification are hydroxylapatite, tricalcium phosphate, and combinations thereof, with the possibility of minor additions of other ceramics or metals.
What analysis techniques are described by ASTM F1609-23?
To ensure compliance, materials must undergo rigorous testing, including:
Mechanical testing: tensile testing, tensile strength, shear strength, fatigue strength
FILAB Laboratory supports you with your analysis needs according to ASTM F1609-23
Importance of ASTM F1609-23
ASTM F1609-23 is a fundamental standard in the medical device industry for hydroxyapatite-based products. It ensures that these materials comply with the strictest quality requirements, thereby promoting the safety and effectiveness of medical devices and improving patients’ lives.
To learn more about this standard and its application in your industry, please do not hesitate to contact us. We are here to guide you toward high-quality, standards-compliant solutions for your medical devices.
Why conduct analysis according to ASTM F1609-23?
ASTM F1609-23 is crucial to the medical device sector for several reasons:
FILAB offers a wide range of services, some accredited to COFRAC 17025, to support you in evaluating your medical devices
The FILAB laboratory has developed extensive expertise in chemical analysis and materials characterization to provide you with a comprehensive service for the chemical characterization of all your biomaterials:
- AET calculation
- Validation of extraction completeness according to ISO 10993-12
- Analysis and quantification of organic and inorganic residues by ICP, GC\/MS, LC, HS\/GCMS, CLI, etc.
- Identification of impurities by LC-QTOF
- TOC\/TCN analysis
- Inorganic residue analysis
- Particulate contamination analysis
With our 3 service levels – analysis, expertise, and R&D support – our laboratory supports industrial companies of all sizes and from every sector in solving their industrial challenges. FILAB provides you with the know-how and expertise of its team and offers you a dedicated technical contact.
