Chemical Characterization and Its Importance in Medical Devices
Chemical characterization is a critical process that evaluates the safety and biocompatibility of the chemical components used in the manufacturing of medical devices. This analysis helps optimize material selection during the design phase and enhances production safety by identifying potential risks.
Benefits of Chemical Characterization
- Safe Material Selection: Identifying the right materials ensures device performance and safety.
- Risk Management: Chemical risks of materials are analyzed to implement preventative measures in the production process.
- Regulatory Compliance: Compliance with ISO standards facilitates the approval of medical devices in international markets.
Chemical Characterization Process
1. Material Identification:
The chemical components of the materials used are thoroughly analyzed.
2. Chemical Analysis:
The chemical properties of devices that come into direct or indirect contact are examined.
3. Risk Assessment:
The obtained results are evaluated toxicologically and potential risks are identified.
4. Reporting:
All analyses are reported in accordance with international standards and presented to manufacturers.
ISO 10993 and Chemical Characterization
The ISO 10993 standards are the basis for the biological evaluation of medical devices. These standards include:
- ISO 10993-1: The requirement for material characterization in the risk assessment process.
- ISO 10993-18: Determination of the chemical properties of materials.
- ISO 10993-17: Use of chemical characterization data in toxicological risk assessment.
These standards guide the optimization of reliability testing and ensure the biological safety of medical devices.
Why Choose Oxigen Analiz?
At Oxigen Analiz, we perform chemical characterization tests of your medical devices in full compliance with international standards.
Full compliance with ISO 10993 standards
Reliable toxicological assessment services
Fast and accurate analysis results