Nickel Elution Studies

Nickel is widely used in medical device alloys but can cause allergic or toxic reactions if it leaches into the body. Nickel elution studies quantify the release of nickel ions under simulated use conditions to confirm compliance with ISO and FDA safety limits. Invision Biomedical offers validated nickel release testing that ensures both patient safety and regulatory compliance.

Applications & Methods

Simulated Use Testing

Devices are exposed to relevant conditions that mimic clinical environments.

Quantification of Nickel Release

Sensitive detection methods measure even trace amounts of nickel ions.

Compliance with International Standards

Results align with ISO 10993-18 chemical characterization and FDA guidance.

Risk Assessment for Patient Safety

Data supports toxicological evaluations, ensuring devices meet strict safety thresholds.

Frequently Asked Questions

Why is nickel elution testing important?

Nickel is a common allergen, and uncontrolled release can create serious patient safety concerns.

How are nickel release levels measured?

Specialized extraction studies paired with ICP-MS detection quantify nickel ion migration.

What are the regulatory thresholds for safety?

ISO and FDA standards define acceptable limits for nickel release, which must be validated through testing.

How does Invision Biomedical conduct nickel studies?

We perform validated protocols under simulated use conditions, providing regulator-ready reporting.

Achieve Compliance with Nickel Elution Studies

Protect patients and streamline regulatory approval with precise nickel release testing.