What is Chemical Characterization in Medical Products? How Critical is its Impact on Safety?

Among the most crucial tests ensuring the safety of medical products, chemical characterization has become indispensable in modern healthcare technology. But what exactly is chemical characterization, and why is it so essential?

What is Chemical Characterization?

Chemical characterization refers to the process of identifying and quantifying the chemical substances present in a material. Especially for medical devices, it is a vital procedure that determines if any potentially harmful chemicals can leach from the product into the human body.

Why is it Important in Medical Devices?

• Directly affects patient safety.
• Ensures compliance with international standards (e.g., ISO 10993-18).
• Helps avoid product recalls and legal risks.
• Supports long-term biocompatibility evaluations.

Which Products Require This Test?

Reliable Testing with TTS Laboratuvar

TTS Laboratuvar is one of Turkey’s leading laboratories specialized in chemical characterization testing for medical products. With an experienced team and internationally accredited infrastructure, TTS ensures reliable and regulatory-compliant results.

To ensure medical products are safe for use, chemical characterization must be conducted regularly. These tests not only meet legal requirements but also boost brand reputation and ensure patient satisfaction.

Frequently Asked Questions

When should chemical characterization be performed?

Ideally during the early stages of product development and after any formulation change.

Is this test mandatory?

In many regions, especially for implantable devices, it is required by health authorities.

Where does TTS Laboratuvar conduct this test?

All analyses are conducted in their accredited laboratories. For more information, click here.