--- type: "WebPage" title: "ASTM F1185 analysis laboratory" description: "You would like 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..." resource: "https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/astm-f1185-f1088/" tags: ["EN", "pll_652666936f99d", "Thomas ROUSSEAU"] timestamp: "2026-03-19T15:38:36Z" published: "2024-02-09T14:04:50Z" language: "en" author: "Laure Durieux" --- # ASTM F1185 analysis laboratory ## You would like 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)](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/hap-powder-characterization.md) 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](https://filab.fr/en/our-technical-resources/laboratory-analysis-icp-icp-ms-icp-aes.md) 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](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices.md) 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 : 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**](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices.md) to provide you with a comprehensive service for the chemical characterisation of all your biomaterials: [Chemical characterisation of materials in accordance with ISO 10993-18:2018](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md) - [Calculation of TEA](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/medical-devices-calculation-aet.md) - [Validation of extraction completeness according to ISO 10993-12 standard](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md) - Search for and determination of organic and inorganic residues by [ICP](https://filab.fr/en/our-technical-resources/laboratory-analysis-icp-icp-ms-icp-aes.md), [GC/MS](https://filab.fr/en/our-technical-resources/gas-chromatography-analysis-lab-gc/tdu-gc-ms-analysis/), [LC](https://filab.fr/en/laboratory-mass-spectrometry-unknown-spike-analysis.md), [HS/GCMS](https://filab.fr/en/our-technical-resources/hs-gc-ms-analysis-in-the-laboratory.md), [IC](https://filab.fr/en/our-technical-resources/laboratory-ion-chromatography.md) - Identification of impurities by [LC-QTOF](https://filab.fr/en/our-technical-resources/laboratory-for-lc-qtof-analysis.md) [Analysis of cleaning residues in accordance with ISO 19227:2018](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) - [HCT/COT analysis](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/hct-toc-analysis-cleaning-process-validation-for-medical-devices.md) - Analysis of inorganic residues - [Analysis of particulate contamination](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-identification-counting-particulate-contmaninant.md) [Development, transfer and validation of analytical methods](https://filab.fr/en/our-services/rd/life-cycle-of-an-analytical-method-in-the-laboratory/analytical-development/) [Problem solving](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures.md) :[part breakage](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures/laboratory-analysis-ruptures.md), [surface contamination](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant.md), [adhesion problems](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/medical-devices-problematic-adhesion-of-pah-on-femoral-head.md),[corrosion](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-expertise-and-analysis-of-corrosion.md) ... Analysis and characterisation of [HAP powders](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/hap-powder-characterization.md) With our 3 levels of services - [analysis](https://filab.fr/en/our-services/our-analysis-services.md), [expertise](https://filab.fr/en/our-services/our-expertise-services.md) and [R&D support](https://filab.fr/en/our-services/rd.md) - 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. ## Notre FAQ What is ASTM F1185 analysis? ASTM F1185 analysis defines the chemical and crystallographic requirements for **medical-grade hydroxyapatite used in surgical implants**. It ensures that the material meets strict composition criteria, including calcium/phosphorus ratio and phase purity. What is ASTM F1088 testing? ASTM F1088 testing focuses on the characterization of **beta-tricalcium phosphate (β-TCP)** used in medical devices.  It evaluates key parameters such as chemical composition, particle size, porosity, and mechanical properties to ensure material performance and safety. What techniques are used for ASTM F1185 analysis? ASTM F1185 analysis typically involves: - ICP-MS or ICP-OES for elemental impurities   - X-ray diffraction (XRD) for phase identification   - chemical analysis of calcium and phosphorus content   These techniques ensure that hydroxyapatite meets the required purity and structural specifications. What types of materials are tested according to ASTM F1185 and ASTM F1088? These standards apply to: - hydroxyapatite powders and raw materials   - beta-tricalcium phosphate (β-TCP)   - biomaterials used in implants or bone substitutes   - materials used for coatings or implant manufacturing   They cover both raw materials and components used in medical devices. How can I request a quote for ASTM F1185 or ASTM F1088 analysis? To request a quote for **ASTM F1185 or ASTM F1088 analysis**, you can contact our team via our contact form, by phone, or by email. Simply provide details about your requirements, such as: - type of material (hydroxyapatite, beta-TCP, etc.)   - required analysis (ASTM F1185, ASTM F1088, or related testing)   - applicable standards   - project urgency   - number of samples   Our experts will send you a **customized technical and financial proposal within 24–48 hours**. What is the typical turnaround time for ASTM F1185 and ASTM F1088 analysis? Turnaround times for **ASTM F1185 and ASTM F1088 analysis** vary depending on the type of testing and the complexity of the project, including the number of samples and analytical techniques required. However, FILAB is committed to providing fast and flexible timelines, tailored to your industrial constraints and project urgency. How to get a quote from FILAB? To obtain a quote, you can contact our team via our contact form, by phone, or by email. Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours. What is the typical duration of the analysis? Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project. However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.