Plastics Additives Screening

Plastic additives—such as stabilizers, plasticizers, and colorants—enhance material performance but can migrate from medical devices into the body. Screening for these additives ensures that device materials remain safe, stable, and compliant with biocompatibility standards. At Invision Biomedical, we deliver comprehensive plastics additive screening that satisfies FDA and ISO guidelines.

Applications & Methods

Identification of Additives

We analyze device materials to determine which additives are present.

Migration and Leachability Assessment

Studies evaluate whether additives can leach under use or storage conditions.

Risk Evaluation Against Safety Thresholds

Toxicological assessment ensures additive levels are safe for patients.

Regulatory-Compliant Reporting

Results are formatted for FDA and ISO submissions, reducing approval delays.

Frequently Asked Questions

What additives are commonly found in plastics?
Plasticizers, colorants, stabilizers, and flame retardants are typical additives screened in medical devices.
Additives may migrate into patients, raising toxicological and performance concerns.
We use advanced chromatographic and spectrometric methods to characterize additives precisely.
Our validated methods and detailed reports align with FDA and ISO 10993 standards.

Screen Plastics for Patient Safety and Compliance

Confirm your materials are safe, stable, and regulator-ready.