In Europe, the Medical Device Regulation (MDR) imposes rules for market access. In Annex II section 6.1, the framework requires physical and chemical characterizations of the device as well as proof of conformity with product specifications. For synthetic bone substitutes made from β-tricalcium phosphate or hydroxyapatite, specifications for materials properties can be found in ISO 13175-3, ISO 13779-2 and -6.
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For manufacturers targeting the US market through a 510(k) submission, two FDA guidance documents cover the physical and chemical testing requirements for synthetic and animal-derived bone substitutes both for dental and orthopedic applications (1, 2). References to various ISO and ASTM standards are outlined, including ASTM F1088, ASMT F1185 and ASTM F1581.
At RMS Foundation, we provide all the bench test characterizations required for calcium phosphate bone substitutes, including chemical analyses (impurity elements, Ca/P ratio, crystalline phase purity), dissolution tests, characterizations of powder, granule, or pore morphology, and mechanical tests. To facilitate your task of identifying the relevant tests, we have compiled the requirements into six informative FAQ sheets categorized by target market and product type:
| Europe/MDR: | USA/FDA: |
| β-Tricalcium phosphate (β-TCP) | Dental: synthetic |
| Hydroxyapatite (HA) | Dental: animal-derived |
| Hydroxyapatite powder | Orthopedic |
In each scenario, we offer an attractive analysis package, including a detailed report outlining the test procedures, statistical evaluation, and a critical assessment of the results. All our test methods are validated and accredited according to ISO/IEC 17025:2017.
Are you a coating manufacturer? Stay tuned!
The FDA recently released a draft of a new guidance document coatings of orthopedic devices (3). We offer comprehensive analyses, including microstructure analyses (ASTM F1854), mechanical testing (e.g., ASTM F1044, F1160), and dissolution testing (e.g., ASTM F1926). Once the final guidelines are available, we will ensure that we provide the complete testing package for you.
Selection of tests, number and quantity of sample material
Consult the FAQ sheets on our webite!
FDA guidance documents:
- "Dental Bone Grafting Material Devices - Class II Special Controls Guidance Document for Industry and FDA staff", issued on April 28, 2005.
- "Resorbable Calcium Salt Bone Void Filler Device - Class II Special Controls Guidance Document for Industry and FDA staff", issued on June 2, 2003.
- "Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices - Draft Guidance for Industry and FDA Staff", January 2024
Contact for bioceramic tests:
Dr. Christoph Stähli
Phone +41 32 644 20 44
