You want to analyse the hydroxylapatite and beta-tricalcium content of your DM according to the ASTM F1185-25
Firstly, the ASTM F1185-23 specification is evolving to meet the requirements of ICH Q3D and USP 233.
What does ASTM F1185-23 say ?
ASTM F1185-23 governs the physicochemical and mechanical properties of hydroxyapatite (HAP) materials used in medical devices. This standard provides guidelines on characterisation tests, composition specifications, porosity, density, flexural strength, and many other parameters crucial to assessing the quality and performance of these materials.
This standard concerns the analysis of elemental impurities by ICP in hydroxyapatites. It covers the chemical and crystallographic requirements for hydroxylapatite used in surgical implants. For a material to qualify as medical grade hydroxylapatite, it must comply with this specification.
The FILAB laboratory can assist you with your analysis needs in accordance with ASTM F1185-23 standard
Importance of the ASTM F1185-23 standard
ASTM ASTM F1185-23 is fundamental pillar of the hydroxyapatite medical device industry. It guarantees that these materials comply with the most stringent quality requirements. In this way, they promote the safety and efficacy of medical devices, and improve patients’ lives.
To find out more about these standards and how they apply to your sector, please contact us. We’re here to guide you towards high-quality, standards-compliant solutions for your medical devices.
Why carry out analyses in accordance with ASTM F1185-23 ?
The ASTM F1185-23 standard is crucial for the medical devices sector 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.
