Would you like to analyze the hydroxyapatite in your medical devices according to ASTM F1185-23?
First of all, the ASTM F1185-23 specification is evolving to meet the requirements of ICH Q3D and USP 233.
What does ASTM F1185-23 say?
The ASTM F1185-23 standard governs the physicochemical and mechanical properties of hydroxyapatite (HAP) materials used in medical devices. This standard provides guidelines for characterization testing, composition specifications, porosity, density, flexural strength, and many other crucial parameters used to assess the quality and performance of these materials.
This standard covers the analysis of elemental impurities by ICP in hydroxyapatites. In fact, it covers the chemical and crystallographic requirements for hydroxyapatite used in surgical implants. For a material to be classified as medical-grade hydroxyapatite, it must comply with this specification.
The FILAB laboratory supports you with your ASTM F1185-23 analysis requirements
Importance of ASTM F1185-23
ASTM F1185-23 is a fundamental pillar of the medical device industry based on hydroxyapatite. It ensures that these materials meet the strictest quality requirements. It therefore promotes the safety and effectiveness of medical devices and improves patients’ quality of life.
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 carry out analysis according to ASTM F1185-23?
ASTM F1185-23 is crucial for 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.
