ISO 10993-18 Chemical Characterization Testing (LC-MS\/MS)
The ISO 10993 series of standards is widely recognized for providing a framework to ensure the safety and biocompatibility of medical devices. Within this context, ISO 10993-18 focuses specifically on chemical characterization testing. This service plays a crucial role in ensuring that new or modified medical devices do not contain harmful substances that could adversely affect patients.
The primary goal of ISO 10993-18 is to identify and quantify the presence of potential toxicants, allergens, or other chemicals that might be leached into patient contact areas. This testing helps manufacturers comply with regulatory requirements and ensures product safety throughout their lifecycle. The process involves detailed chemical analysis using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS\/MS), which is highly sensitive and selective.
The LC-MS\/MS technique allows for the detection of trace amounts of chemicals, even those present at levels below the limit of quantification. This sensitivity ensures that no harmful compounds are overlooked during testing. The service covers a wide range of materials commonly used in medical devices such as plastics, metals, textiles, and adhesives.
Before starting the LC-MS\/MS analysis, it is essential to properly prepare specimens according to ISO standards. This process includes extracting target compounds from the material using appropriate solvents and then diluting the extract for injection into the mass spectrometer. The preparation steps are critical as they influence the accuracy of subsequent measurements.
The LC-MS\/MS instrumentation used in this service is state-of-the-art, equipped with advanced software that enhances data acquisition and interpretation capabilities. Our experts carefully analyze each sample to ensure compliance with relevant international standards like ISO 10993-18. They also provide detailed reports summarizing findings along with recommendations for any necessary modifications or improvements.
One key advantage of using Eurolab for ISO 10993-18 chemical characterization testing is our comprehensive understanding of global regulatory requirements. Our team stays updated on the latest guidelines and best practices, ensuring that every test conducted adheres to current standards. Additionally, we offer customized solutions tailored specifically to your needs—whether you require additional analytical methods or specialized expertise.
Another significant benefit lies in our commitment to delivering accurate results promptly. By leveraging advanced technology combined with experienced personnel, we can provide timely feedback crucial for product development timelines. Furthermore, our transparent communication ensures that all stakeholders are kept informed about the progress of each project.
Scope and Methodology
| Step | Description |
|---|---|
| Sample Preparation | Involves extracting target compounds from the material using appropriate solvents followed by dilution for injection into the mass spectrometer. |
| Instrumentation Setup | Ensures correct calibration of LC-MS\/MS equipment prior to analysis. |
| Data Collection & Analysis | Uses advanced software to analyze extracted ion chromatograms and spectra generated during the run. |
Eurolab Advantages
- Expertise in global regulatory requirements ensures compliance with current standards.
- Advanced instrumentation provides accurate and reliable results.
- Customized solutions meet specific client needs.
- Prompt delivery of timely feedback supports efficient product development cycles.
Customer Impact and Satisfaction
- Enhanced trust among stakeholders due to transparent communication throughout the process.
- Increased confidence in meeting regulatory expectations thanks to our expertise in international standards.
