Chemical Characterization for Medical Devices: Ensuring Safety and Compliance
Comprehensive Chemical Characterization Services for Medical Devices
Chemical Characterization for Medical Devices: Ensuring Safety and Compliance
Chemical characterization is a crucial step in ensuring the biological safety of medical devices. This process involves identifying and analyzing the chemical substances present in the materials used for manufacturing or found in finished medical devices. Proper chemical characterization can exempt certain biocompatibility tests, such as mutagenicity, subchronic systemic toxicity, chronic toxicity, and long-term implantation studies.
Key Processes in Chemical Characterization for Medical Devices
Our chemical characterization services include:
- Identification of Manufacturing Materials: Accurate identification of materials used in medical device production.
- Chemical Composition Analysis: Detailed qualitative and quantitative analysis of manufacturing materials.
- Assessment of Chemicals from Manufacturing Processes: Analysis of chemicals arising from production, including auxiliary substances, contaminants, and sterilization residues.
- Estimation of Chemical Release: Prediction of potential chemical release from devices under clinical usage conditions.
- Detection of Released Chemicals: Identification of chemicals released from medical devices during clinical use.
Advanced Testing Methods for Chemical Characterization
Our laboratory uses state-of-the-art testing methods to ensure precise chemical characterization:
- Comprehensive Extraction Techniques
- FTIR Testing for Non-Volatile Residues
- GC-MS Testing for Volatile and Semi-Volatile Organic Extracts
- ICP-MS Testing for Inorganic and Heavy Metal Extracts
- LC-MS Testing for Non-Volatile Organic Extracts
- UV-Vis Spectrophotometry for Dye Analysis
Viscosity and pH Measurements Compliance with ISO 10993 Standards
Nanolab Laboratories adheres to the latest ISO 10993 standards, ensuring thorough evaluation and testing within a risk management framework. Our services cover:
- Identification and quantification of degradation products
- Establishment of allowable limits for leachable substances
- Comprehensive chemical characterization of materials
Our Extractables & Leachables (E&L) testing includes:
- Risk Assessment: Comprehensive review of all materials involved.
- Identification of Extractables: Extraction of potentially leachable compounds using appropriate solvents.
- Toxicological Risk Evaluation: Assessment of risks to patients through extractables and leachables.
- Quantification of Leachables: Measurement of harmful leachables in the final product.
- Detailed Reporting: Comprehensive reports to help clients meet compliance standards.
Why Choose Nanolab Laboratories?
At Nanolab Laboratories, our expert chemists utilize advanced equipment and techniques to deliver tailored chemical characterization services. Our commitment to quality ensures that your medical devices meet the highest safety and regulatory standards.
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