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
ASTM F1609 testing in an accredited laboratory
As a specialized ASTM testing laboratory, FILAB provides advanced ASTM F1609 testing services to support medical device manufacturers in the characterization of calcium phosphate coatings used in implantable devices.
Our ASTM F1609 laboratory performs a full range of analyses, including:
- surface and coating evaluation (thickness, morphology, porosity)
- mechanical testing (adhesion strength, shear resistance, fatigue)
These tests ensure compliance with ASTM F1609 requirements and support regulatory submissions (FDA, MDR).
ASTM F1185 characterization
ASTM F1185 characterization of Hydroxyapatite
The ASTM F1185 standard defines the chemical requirements for hydroxyapatite used in surgical implants.
An ASTM F1185 characterization includes:
verification of chemical purity
trace element analysis
identification of crystalline phases
assessment of material consistency
In practice, ASTM F1185 characterization is often combined with ASTM F1609 testing to ensure both the raw material and the coating meet industry standards.
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.
Our FAQ
ASTM F1609 testing evaluates the chemical, structural, and mechanical properties of calcium phosphate coatings used on medical implants.
An ASTM F1609 laboratory performs coating characterization, including chemical analysis, crystallography, and mechanical testing to ensure compliance with industry standards.
ASTM F1185 characterization focuses on the chemical composition and purity of hydroxyapatite used in implantable devices.
Combining both standards ensures full control over the material (ASTM F1185) and the final coating performance (ASTM F1609).
To receive a quote, you can contact our teams via our contact form, by phone, or by email.
Simply provide details about your requirements, such as the type of material, the analysis to be performed (e.g. ASTM F1906-23 testing), any applicable standards, urgency, and the number of samples.
Our experts will then send you a tailored technical and financial proposal within 24 to 48 hours.
Turnaround times vary depending on the type of analysis and the complexity of the project.
However, FILAB is committed to delivering fast lead times, adapted to your industrial constraints and urgency, particularly for medical device testing such as ASTM F1906-23.
