Additive/Plasticizer Migration Testing in Device Materials
Medical devices are often made from complex materials, including polymers that may contain additives and plasticizers. These components can influence the performance and biocompatibility of the device. Additives such as antioxidants, stabilizers, and plasticizers play a critical role in ensuring the stability, flexibility, and durability of these materials. However, they also pose potential risks if they migrate into contact with biological tissues or bodily fluids.
Plasticizer migration refers to the process by which plasticizers diffuse from the polymer matrix into the surrounding environment, such as human skin or blood. This phenomenon can have significant implications for medical devices, especially those intended for prolonged use in close proximity to body tissues. Regulatory bodies and industry standards mandate that manufacturers ensure the safety of these materials by conducting rigorous testing.
The International Organization for Standardization (ISO) provides a framework through ISO 10993-12: Biological Evaluation of Medical Devices—Part 12: Additives in Biomaterials, which specifies methods for evaluating the migration of additives and plasticizers from medical devices. This standard ensures that healthcare professionals can rely on the safety and efficacy of these devices.
Our laboratory offers specialized testing services to meet these stringent requirements. Our team of experts uses advanced analytical techniques such as gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) to accurately measure the levels of additives and plasticizers that may migrate from medical devices.
Industry Applications
| Application | Description |
|---|---|
| Polyurethane | Used in orthopedic implants and prosthetics. Ensures flexibility and durability. |
| Polyvinyl chloride (PVC) | Commonly used in catheters and blood bags. Enhances flexibility and reduces costs. |
| Silicone | Used in breast implants, contact lenses, and surgical gloves. Provides biocompatibility and smooth texture. |
| Material Type | Typical Additives/Plasticizers |
|---|---|
| Polyethylene (PE) | Ethylene vinyl acetate (EVA), antioxidants. |
| Polypropylene (PP) | Monoethyl acrylate, plasticizers. |
| Polycarbonate (PC) | Bisphenol A, flame retardants. |
Why Choose This Test
- Compliance with international standards such as ISO 10993-12.
- Expertise in advanced analytical techniques like GC-MS and LC-MS/MS.
- Accurate measurement of additive and plasticizer migration levels.
- Support for regulatory submissions to ensure device approval.
- Experience with diverse medical devices including implants, catheters, and prosthetics.
International Acceptance and Recognition
The testing methods we employ are recognized globally by regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. Compliance with ISO 10993-12 ensures that your device meets the highest standards of safety and biocompatibility.
Our laboratory is accredited to conduct these tests according to international guidelines, ensuring that our results are credible and accepted worldwide. We provide comprehensive reports that include detailed test protocols, data analysis, and compliance statements, making it easier for you to navigate the regulatory process.
