ISO 10993-18 Chemical Characterization Testing

ISO 10993-aligned analytical expertise

Global laboratory network  

Predictable turnaround time  

TÜV SÜD provides ISO 10993-18 chemical characterization and Extractables & Leachables (E&L) testing to support biocompatibility risk assessments and regulatory submissions for medical devices. Our services support manufacturers in meeting ISO 10993 biocompatibility requirements and global regulatory expectations.  

Identification and quantification can be performed for a wide range of medical device materials and components, including analysis of volatile, semi-volatile, and non-volatile organic compounds (VOC/SVOC/NVOC), as well as trace metals and elemental impurities.  

Analytical Chemistry & Medical Device Testing Services  

• ISO 10993-18 Chemical Characterization Testing  
• Extractables & Leachables (E&L) Testing – Targeted and Untargeted Analysis  
• Elemental Impurities, Metals, and Trace Element Analysis  
• Ethylene Oxide (EO) Residual Testing for Medical Devices  

Why Medical Device Manufacturers Choose TÜV SÜD

Expertise and Compliance  
• ISO 10993-aligned testing expertise  
• ISO/IEC 17025-accredited testing facility  

Reliable Project Execution  
• Dedicated project management  
• Predictable turnaround performance  

Global Reach and Integrated Services  
• Access to TÜV SÜD's global testing network  
• Support for regulatory compliance across global markets  

Avoid Delays in Biocompatibility Submissions  

Incomplete chemical characterization of medical devices can delay regulatory reviews and biocompatibility risk assessments. Work with a laboratory designed for predictable study execution and regulatory confidence.  

Start Your ISO 10993-18 or E&L Study  

Connect with our experts to discuss your device, testing scope, and analytical strategy for chemical characterization.  

Speak with a Testing Expert