The Applied Technical Services Family of Companies (ATS FoC) conducts medical device biocompatibility testing to demonstrate that devices and their materials are biologically safe for their intended use. Biocompatibility refers to a device’s ability to interact with the body without causing unacceptable biological effects. Our evaluations help manufacturers identify and assess biological risks related to device materials, patient contact, and intended use, supporting comprehensive biological evaluation programs.
What ISO 10993 Tests Can a Biocompatibility Testing Laboratory Perform?
Our laboratory performs ISO 10993 series testing, selecting tests based on device type, materials, body contact characteristics, and identified biological risks. Our capabilities include:
- Cytotoxicity, sensitization, and irritation testing
- Chemical characterization and extractables and leachables evaluations
- Biological evaluations using in vitro and applicable alternative methods
Testing may also address systemic toxicity, genotoxicity, implantation, hemocompatibility, and other biological endpoints as indicated by the device risk assessment. ISO 10993 testing follows defined sample preparation, extraction conditions, test methods, and evaluation criteria to produce meaningful biological safety data.
About Our Medical Device Biocompatibility Testing Services
Our biocompatibility testing supports manufacturers through product development, qualification, and regulatory preparation. We offer in vitro cytotoxicity testing (ISO 10993-5), sample preparation and extraction (ISO 10993-12), and irritation evaluations (ISO 10993-23). We also provide chemical characterization and extractables and leachables investigations (ISO 10993-18), including analysis of organic and inorganic compounds. Our laboratory operates under ISO/IEC 17025 accredited quality systems, with qualified personnel, controlled procedures, appropriate equipment, and documented methods to ensure reliable testing and reporting.
Key capabilities include:
- ISO 10993 biological endpoint testing
- Chemical characterization and extractables and leachables evaluations
- In vitro and alternative testing approaches
How Does ISO 10993 Guide Medical Device Biological Evaluation?
ISO 10993 offers a framework for evaluating biological risks associated with medical devices, rather than mandating a uniform testing program. Evaluations consider device materials, contact location, nature and duration of exposure to determine relevant biological endpoints. ISO 10993 assessments are part of a broader risk management process, including principles from ISO 14971. This risk-based approach helps manufacturers select suitable tests, interpret biological safety data, and address potential device risks.
Contact Us
Contact our medical device testing laboratory to discuss your biocompatibility testing needs. Submit an online inquiry to learn more about our testing programs and ISO 10993 capabilities, or call +1 (888) 287-5227 to speak with a specialist.
