Chemical Characterization

Particularly for medical devices that come into direct or indirect contact with the body, meticulous analysis before and after the manufacturing process is of great importance. Foremost among these analyses is chemical characterization.

What is Chemical Characterization?

Chemical characterization is a process that involves a detailed analysis of the chemical composition of materials used in the manufacturing of a medical device. This process identifies all potential chemical substances within the device's structure or on its surface and assesses any possible harmful effects.

Through chemical characterization performed according to international standards, potential risks of the device to human health can be identified in advance, and necessary measures can be taken.

Why Should Chemical Characterization Be Performed?

The ISO 10993 series of standards, one of the most fundamental for evaluating the biocompatibility of medical devices, mandates chemical characterization tests. These tests facilitate

• identification of toxicological risks,
• identification of undesirable or hazardous chemicals within the product's structure,
• ensuring compliance with regulations and international standards,
• enhancing the reliability and quality of the product intended for market.

These analyses are particularly crucial for invasive (introduced into the body) and implanted devices.

For which products is chemical characterization required?

Chemical characterization tests are frequently performed on the following groups of medical devices:

• Invasive medical devices such as catheters, stents, and needles
• Surgical hand instruments
• Dental implants and prostheses
• Wound care products
• Products that come into contact with the eyes, such as contact lenses
• Single-use medical devices

Which tests are performed as part of chemical characterization?

• Comprehensive Extraction
• FTIR Test for non-volatile residues or extracts – ISO 10993-18, ISO 10993-12, ISO 10993-17
• GC-MS Test for volatile and semi-volatile organic extracts – ISO 10993-18, ISO 10993-12, ISO 10993-17
• ICP-MS Test for inorganic and heavy metal extracts – ISO 10993-18, ISO 10993-12, ISO 10993-17
• LC-MS Test for non-volatile organic extracts – ISO 10993-18, ISO 10993-12, ISO 10993-17
• UV-Vis Spectrophotometry for dye evaluation
• Viscosity, pH value

In our laboratory, we offer chemical characterization services in accordance with ISO 10993 standards, utilizing international methodologies and state-of-the-art equipment. Contact us to ensure the safety and regulatory compliance of your medical devices.