Ceramics

At the RMS Foundation we can offer you the following services in the area of ceramic testing:

Bundle analyses for product registration of bone graft substitutes

Description:

Our analysis packages include all chemical, physical and morphological analyses required for the preclinical characterization of bone graft substitute products according to international standards in a single attractive package. Depending on the product composition, we offer packages for product registration on the European market according to the MDR or on the US market according to FDA guidelines. Further information is provided on our information sheets.

 

Europe/MDR:

USA/FDA:

Standard(s):
  • ISO 13175-3
  • ISO 13779-3
  • ISO 13779-6
  • ASTM F1088
  • ASTM F1185
  • ASTM F1581
  • Medical Device Regulation (MDR)
  • FDA Guidances
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Equipment:  

 

 

Curing time and reaction temperature

Description: Determination of the curing time and maximum reaction temperature of exothermically reacting cement pastes according to ASTM F451.
Standard(s): ASTM F451
Newsletter:  
Equipment: Center 309 Data Logger with Thermocontrol TKI20/50FIM.K thermocouples

 

 

Cohesion of pastes and cements

Description: In a specially developed test setup, we measure the cohesion of pastes and cements in an aqueous environment. The result provides information on how quickly a paste dissolves or disintegrates in water. The test takes place at room temperature and is suitable for paste volumes from 0.5 to 10 mL.
Standard(s):  
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Equipment: Precision scale Mettler-Toledo PR5002

 

 

Identification and quantification of ceramic solution products

Description: In this test, the soluble fractions of ceramic products are determined according to ISO 10993-14.
Standard(s): ISO 10993-14
Newsletter:
  • NL 31:
  • NL 27:
Equipment: Climatic chamber Feutron KPK 200 / Shaking table GFL Type 3017 / Agilent 7700x ICP MS

 

 

Identification of main crystalline phases (XRD)

Description: The qualitative identification of main crystalline phases in ceramic and metallic materials is performed by matching an X-ray diffractogram (XRD) with a crystal structure database. Depending on the complexity of the diffractogram, phases with a proportion of less than ten percent by weight can be identified.
Standard(s): Not accredited
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Equipment: Bruker D8 Advance diffractometer with CuKα radiation and LynxEye XE energy dispersive linear detector / current ICDD PDF-4+ structure database / Match! Identification Program

 

 

Phase purity of β-tricalcium phosphate and hydroxyapatite

Description: X-ray diffraction (XRD) is used to quantitatively determine the phase purity of β-tricalcium phosphate bone substitute materials. The evaluation by Rietveld refinement corresponds to the latest state of the art and is carried out according to ASTM F1088 and following ISO 13175-3 and ISO 13779-3.
Standard(s): ASTM F1088 / ISO 13175-3 / ISO 13779-3
Newsletter:  
Equipment: Bruker D8 Advance diffractometer with CuKα radiation and LynxEye XE energy dispersive linear detector / current ICDD PDF-4+ structure database / BGMN and Profex Rietveld refinement programs.

 

 

Trace element analysis of calcium phosphates (ISO 13175-3, ASTM F1088, F1185 and F1581)

Description:

Calcium phosphate bone substitutes are tested for heavy metals and other impurities by inductively coupled plasma mass spectrometry (ICP-MS). The analysis provides the levels of As, Cd, Hg, Pb, Bi, Sb, Sn, Ag, Cu, Mo, Fe, and Cr, and at the same time provides an "element screening" of 50 additional foreign elements, according to the maximum allowable values as specified in ISO 13175-3, ASTM F1088, F1185, and F1581.

Standard(s): ISO 13175-3 / ASTM F1088 / F1185 / F1581
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Equipment: Agilent 7700x ICP-MS

 

 

Dissolution test on calcium phosphates (ISO 13175-3)

Description: The dissolution properties of resorbable bone substitute materials made of calcium phosphate are determined in an in vitro dissolution test according to ISO 13175-3. For this purpose, changes in pH and the release of Ca in the incubation solution are recorded.
Standard(s): ISO 13175-3
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Equipment: Temperature-controlled incubation shaker IKA™ KS 4000i / Agilent 7700x ICP-MS / Mettler Toledo MA235 pH meter

 

 

Dissolution rate of calcium phosphates

Description: Incubation of a sample for 24h in a buffer solution (MES or TRIS) at 37 °C. Continuous measurement of the Ca concentration by means of a Ca-ion-selective electrode. pH determination of the solution at the beginning and at the end of the test. Recommended: tests carried out in parallel on a historical control or a certified reference material.
Standard(s): ASTM F1926
Newsletter:
  • Dissolution rate (ASTM F1926) and solubility product (ISO 13779-6) of calcium phosphates (NL-39)
Equipment: Polymer membrane Ca ion-selective electrode (Metrohm Titrando), pH electrodes

 

 

Solubility product of calcium phosphates

Description: Incubation of a sample for 60 days in diluted phosphoric acid. Subsequent measurement of the pH value and the Ca and P concentrations by means of inductively coupled plasma mass spectrometry (ICP-MS). Calculation of KSP according to ISO 13779-6 (Annex A.8). Recommended: parallel tests on a certified reference material (e.g. NIST calcium hydroxyapatite, SRM 2910).
Standard(s): ISO 13779-6
Newsletter:
  • Dissolution rate (ASTM F1926) and solubility product (ISO 13779-6) of calcium phosphates (NL-39)
Equipment: IKA (KS 4000 i control) incubator shaker, pH electrodes, Agilent 7700x ICP-MS

 

 

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