ICP-MS is the gold standard for elemental analysis, providing precise detection of trace metals at concentrations as low as parts per trillion. For biomedical devices, heavy metals can pose significant risks to patient safety if not controlled. Invision Biomedical uses ICP-MS to support ISO 10993-18 E&L studies, release studies such as nickel elution used for nitinol-based devices, and biomedical device and packaging materials selection.
ICP-MS provides unparalleled sensitivity, detecting elements down to parts per trillion. This ensures early detection of heavy metals that could compromise patient safety.
The technique can simultaneously quantify dozens of metals across the periodic table. This breadth allows comprehensive assessment of potential impurities in a single test run.
ICP-MS results are directly aligned with FDA, EMA, and ISO 10993 requirements. Submissions backed by ICP-MS data face fewer regulatory hurdles and faster review.
Our detailed reports include toxicological context for measured metal levels. This allows manufacturers to demonstrate safety margins and minimize compliance risks.
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Device materials are digested or extracted into a liquid form suitable for analysis. This ensures representative results for all components.
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Samples are introduced into a high-temperature plasma, where elements are converted into ions. This step is essential for accurate detection.
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The ions are separated by mass-to-charge ratio and measured with precision. This produces detailed elemental profiles for every sample.
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Results are compared against regulatory safety thresholds and compiled into submission-ready reports. Toxicological significance is included where applicable.
ICP-MS is critical for ensuring biomedical device and pharmaceutical packaging materials remain free of harmful trace metals. Common applications include:
ICP-MS can detect a wide variety of metals, including nickel, lead, cadmium, mercury, chromium, and arsenic. This broad range ensures that all clinically relevant toxic metals are monitored. Indeed, most of the elements shown in the periodic table above can be assayed using ICP-MS.
Our ICP-MS system can detect elements at extremely low concentrations, often down to parts per trillion. This ensures no potentially harmful impurities go unnoticed.
Even trace amounts of metals can cause allergic reactions or toxic effects in patients. ICP-MS ensures manufacturers can confirm safety before devices reach the market. A particularly pertinent application is for nickel elution from nitinol-based devices. Nickel is a known irritant to human tissues.
Yes, ICP-MS is one of the most widely accepted methods for elemental analysis under ISO 10993-18. FDA and other global agencies frequently require or recommend it.
Partner with Invision Biomedical for precise heavy metals testing that meets global regulatory expectations.
