Chemical Characterization Process in Medical Devices: The Key to Reducing Risks

Today, the safety of medical devices is assessed not only by their functionality but also by their biocompatibility. One of the most critical processes in ensuring product safety is chemical characterization. So how does this medical test work in practice?

What is Chemical Characterization?

Chemical characterization is the process of identifying and quantifying chemical substances that may be released from the materials used in a medical device. It helps predict any potential risks posed to the human body by such chemicals.

How is the Test Process Carried Out?

The process involves several methodical steps to ensure accurate and reliable results:

1. Data Collection

All relevant information such as materials used, type of body contact, and duration is collected.

2. Extraction Phase

The medical device is exposed to solvents to extract any chemicals that may leach out under normal use conditions.

3. Chemical Analysis

The extracted substances are analyzed using advanced techniques such as:

• GC-MS (Gas Chromatography-Mass Spectrometry)
• ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
• LC-MS (Liquid Chromatography-Mass Spectrometry)

4. Risk Assessment

Results are interpreted based on international guidelines (e.g., ISO 10993-18) to determine safety levels.

What to Consider During the Process

• Appropriate solvents and durations must be chosen based on device application.
• Extraction method should reflect clinical use conditions.
• This test should precede biocompatibility testing for more reliable insights.

Secure Testing with TTS Laboratuvar

TTS Laboratuvar offers reliable and internationally compliant medical characterization testing. Their expert staff and ISO-aligned procedures ensure your devices meet the required standards.

Conclusion

When it comes to medical devices, performing a chemical characterization test is a proactive measure to reduce product-related risks. Contact TTS Laboratuvar for certified and efficient testing services.

Frequently Asked Questions

How long does the chemical characterization test take?

Typically between 1 to 3 weeks depending on the product.

Is it mandatory for all devices?

It is mandatory or strongly recommended for all devices in contact with the human body.

Are the results internationally accepted?

Yes, TTS Laboratuvar follows globally recognized standards like ISO 10993-18.