ASTM F1185 analysis laboratory

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.

dispositifs médicaux

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 :

Quality Assurance : This guarantees that the beta-tricalcium phosphate materials used in medical devices comply with strict quality standards.
Patient Safety: By complying with these standards, medical devices are more likely to be safe to use and minimise risks to patients.
Clinical Effectiveness : ASTM F1185-23 standards contribute to the clinical effectiveness of medical devices, guaranteeing their reliability and performance.
Ease of comparison : This standard enables medical device manufacturers and regulators to compare and assess products in a consistent way.
Continuous Innovation : This encourages innovation by providing guidelines for the development of new medical devices based on hydroxyapatite and beta-tricalcium phosphate.

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:

analyses par tamisage

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.

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Thomas ROUSSEAU Scientific and Technical Director
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