Chemical Characterization
Chemical characterization is a systematic analytical process used to identify and quantify chemical constituents in medical device materials. This comprehensive assessment plays a pivotal role in understanding the chemical composition of device materials and their potential interactions with the human body. A critical component of this evaluation is extractables and leachables (E&L) testing, which assesses potentially harmful substances that may migrate from the device into the patient under clinical use conditions. Extractables refer to chemical compounds that can be released from a material under aggressive extraction conditions (e.g., using solvents or elevated temperatures), while leachables are substances that actually migrate under normal conditions of use. This distinction is crucial for evaluating both worst-case scenarios and real-world patient exposure risks.
The primary objectives of chemical characterization include:
✔ Identifying and quantifying chemical substances in device materials
✔ Evaluating biocompatibility by assessing potential toxicological risks
✔ Ensuring patient safety by minimizing exposure to hazardous leachables
✔ Meeting stringent regulatory expectations for medical device approval
Chemical characterization is mandatory for medical device registration under FDA, EU MDR, and other global regulations. Without proper chemical evaluation, manufacturers risk regulatory delays, biocompatibility failures, and patient safety concerns, making this testing essential for successful device development and market approval.
Our Service
Meditronics (a brand of STEMart) provides end-to-end chemical characterization services in full compliance with ISO 10993-18, ISO 10993-17, and ISO 10993-1. Our services cover the entire testing workflow:
1. Study Design & Protocol Development
Customized testing strategies based on device type, material composition, and intended use.
Selection of appropriate extraction conditions (solvents, time, temperature).
2. Sample Preparation & Extraction Studies
Simulated extraction under exaggerated conditions to identify potential leachables.
Controlled extraction studies to assess worst-case scenarios.
3. Advanced Chemical Analysis
Employs state-of-the-art analytical techniques to detect, identify, and quantify a wide range of organic and inorganic compounds, including volatile, semi-volatile, and non-volatile substances, as well as elemental impurities.
4. Data Analysis & Toxicological Risk Assessment
Threshold of Toxicological Concern (TTC) evaluation per ISO 10993-17.
Risk assessment reports supporting biocompatibility conclusions.
Why Choose Meditronics
Meditronics is a trusted partner for medical device manufacturers, offering:
✔ Expert Team
Experienced toxicologists, chemists, and regulatory specialists.
✔ Cutting-Edge Analytical Platforms
Including FTIR, GC-MS, LC-MS, ICP-MS, and more.
✔ Regulatory-Compliant Reports
Detailed documentation for FDA, EU MDR, and global submissions.
✔ End-to-End Support
From study design to toxicological risk assessment.
✔ Fast Turnaround & Cost-Effective Solutions
Optimized testing strategies to accelerate approvals.
By leveraging Meditronics's Chemical Characterization services, manufacturers can:
✔ Ensure compliance with ISO 10993 and global regulations.
✔ Mitigate toxicological risks and enhance patient safety.
✔ Streamline biocompatibility evaluations for faster market access.
Contact Meditronics today to optimize your medical device's chemical safety assessment!
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