Determination of Extractable Elements by Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES) Full Scan

ICP-OES Full Scan is a quantitative analytical technique used to detect and measure trace levels of inorganic and metallic elements that may be extracted from medical device materials. This method helps identify potential toxic elements such as additives, colorants, or residual catalysts that could leach into the body during device use. By simulating worst-case extraction conditions, ICP-OES provides a comprehensive profile of up to 56 elements, supporting risk assessments and regulatory submissions. It is especially valuable during product development, manufacturing validation, and post-market surveillance to ensure device safety and compliance.

Why This Testing is Performed

ICP-OES testing is conducted to assess the presence of extractable inorganic elements that may pose toxicological risks to patients. It supports biocompatibility evaluations and helps manufacturers ensure that materials used in medical devices do not release harmful substances under clinical or exaggerated conditions. This testing is critical for regulatory approval and ongoing safety monitoring.

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Steps in Conducting This Test

1. Sample Preparation: Device materials are cleaned and weighed.
2. Extraction: Samples are exposed to solvents under controlled conditions to simulate worst-case scenarios.
3. Plasma Generation: The extract is nebulized into an argon plasma, where elements are excited.
4. Emission Detection: Emitted light from excited atoms is measured at specific wavelengths.
5. Quantification: Elemental concentrations are calculated using calibration standards.
6. Data Interpretation: Results are compared against toxicological thresholds and used in risk assessments.

Standards, Guidance, and Regulations

• ISO 10993-18: Specifies requirements for chemical characterization of materials, including extractables testing.
• FDA Draft Guidance (2024): Recommends methodological approaches for chemical analysis in biocompatibility assessments.
• EPA Method 6010D: Provides technical details for ICP-OES procedures.