You would like to analyze the hydroxylapatite content of your DM according to ASTM F1609-23
What does ASTM F1609-23 say ?
ASTM F1609-23 is a technical specification that details the requirements for calcium phosphate coatings used in surgical implant applications. Specifically, it covers their composition, application methods, and physical and mechanical characteristics. It covers both particulate and monolithic forms of calcium phosphate materials. The types of coating included in this specification are hydroxylapatite, tricalcium phosphate, and their combinations, with the possibility of minor additions of other ceramics or metals.
What are the analysis techniques described in ASTM F1609-23 ?
To ensure compliance, materials must undergo rigorous testing, including :
Mechanical tests: tensile test, tensile strength, shear strength, fatigue strength
The FILAB laboratory can assist you with your analysis needs in accordance with ASTM F1609-23 standards.
Importance of ASTM F1609-23
ASTM F1609-23 is a fundamental pillar of the hydroxyapatite medical device industry. It guarantees that these materials comply with the most stringent quality requirements. It thus promotes the safety and efficacy of medical devices, and improves patients’ lives.
To find out more about these standards and how they apply to your industry, please contact us. We’re here to guide you towards high-quality, standards-compliant solutions for your medical devices.
Why perform analysis to ASTM F1609-23 standards ?
ASTM F1609-23 standards are crucial to the medical device industry for several reasons :
FILAB offers you a wide range of services, some of which are COFRAC 17025 accredited, to help you assess your medical devices
The FILAB laboratory has developed a wide range of skills in chemical analysis and materials characterisation to provide you with a comprehensive service for the chemical characterisation of all your biomaterials:
- Calculation of TEA
- Validation of extraction completeness according to ISO 10993-12 standard
- Search for and determination of organic and inorganic residues by ICP, GC/MS, LC, HS/GCMS, IC
- Identification of impurities by LC-QTOF
- HCT/COT analysis
- Analysis of inorganic residues
- Analysis of particulate contamination
With our 3 levels of services – analysis, expertise and R&D support – our laboratory supports industrial companies of all sizes and in all sectors in solving their industrial problems. FILAB puts the know-how and expertise of its team at your disposal and provides you with a dedicated technical contact.
