At RMS Foundation, we offer services in various areas including the MedTech, pharma, chemical and machine industry. ICP-MS can be applied to most engineering materials including metallic alloys, ceramics, polymers as well as natural materials and liquid samples, if necessary with a chemical digestion process prior to analysis.
The following examples highlight ICP-MS analyses that were tailored to meet medical device regulatory requirements. The methods were material-specifically validated in internal studies as well as round robin comparisons in order to guarantee accurate results.
Trace elements in bone graft substitutes: RMS Foundation offers a standardized method to demonstrate compliance of implantable calcium phosphate materials with the maximum trace element limits specified in ISO 13175-3 as well as ASTM F1088, F1185 and F1581. Specifically, 10 heavy metals are quantified including arsenic, cadmium, mercury and lead (with limits as low as 3 mg/kg), along with a simultaneous screening for 50 additional elements to identify potential impurities at levels greater than 1000 mg/kg.
Dissolution testing of bone graft substitutes: An in vitro dissolution test has been defined to characterize degradable calcium phosphates according to ISO 13175-3. This test provides the Ca release along with pH changes during dissolution of test specimens in a buffer solution.
Leachables and extractables in compliance with ISO 10993: As part of the biological evaluation of medical devices, products must be tested for surface contaminants in «leachable» and «extractable» studies. RMS Foundation offers incubation tests according to ISO 10993 followed by ICP-MS analysis of more than 60 trace elements released into solution. For additional services in compliance with ISO 10993, please refer to our previous Newsletter 25.
Figure 1: Green: elements detectable by ICP-MS.
Figure 2: Test certificate demonstrating compliance with trace element limits in international standards.
Equipment
Agilent 7700x ICP-MS
• Quantitative analysis of the chemical composition of materials
• Detection of trace elements
• Quantification of degradation products in solution
• Quantification of leachables and extractables
A few hundred milligrams (solid samples) or one millilitre (liquids) is usually sufficient for ICP-MS analysis.
Complementary inorganic techniques available at RMS Foundation
X-ray fluorescence (XRF) and energy-dispersive X-ray spectroscopy (EDX).