The Applied Technical Services Family of Companies’ (ATS FoC’s) medical device testing laboratory offers comprehensive ISO 10993 testing to support manufacturers in evaluating device biocompatibility and biological safety. The ISO 10993 series sets global standards for assessing biological responses to medical devices and their materials. Our services include biological evaluation, chemical characterization, extractables and leachables testing, and toxicological risk assessment. These capabilities help manufacturers identify patient risks, comply with regulatory requirements, and develop safer products.
Which ISO 10993 Tests Are Required for Medical Device Certification?
Medical device manufacturers select ISO 10993 tests according to device materials, intended use, body contact, and exposure duration. There is no universal testing program for all devices. Our laboratory works with clients to develop evaluation strategies that address specific biological risks and regulatory requirements. Common biological evaluation considerations include:
- Cytotoxicity and irritation
- Sensitization and systemic toxicity
- Hemocompatibility and implantation
- Chemical characterization and toxicological assessment
Manufacturers should define testing requirements through a documented biological evaluation process that considers existing data, material composition, and device-specific characteristics.
What ISO 10993 Testing Services Does Our Laboratory Provide?
Our laboratory offers advanced chemical characterization and extractables and leachables testing, matching the capabilities of leading industry laboratories. We evaluate device materials under conditions that reflect intended use, including simulated, exaggerated, and exhaustive extraction methods. These assessments identify substances that may migrate from device materials and pose biological risks. Our services include:
- ISO 10993 18 chemical characterization
- Extractables and leachables testing
- Analytical evaluation threshold determination
- Method development and validation
- Unknown compound identification and structure elucidation
- Simulated use and shelf life studies
- Toxicological risk assessments
We also provide physical and chemical material characterization using thermal analysis, electron microscopy, surface analysis, and spectroscopy. These methods help assess material composition, surface contamination, and potential degradation.
How Does ISO 10993 Testing Assess Biological Risks Associated With Medical Devices?
ISO 10993 testing evaluates biological risks by examining how device materials and their chemical constituents interact with the human body. Chemical characterization identifies substances that may need further toxicological evaluation, while biological testing assesses specific biological responses. Our laboratory provides analytical data to support risk assessments and product development.
Contact Us
Submit an online inquiry or call +1 (888) 287-5227 to discuss your ISO 10993 testing needs. Our technical team will help you develop a testing strategy tailored to your device materials, intended use, and regulatory goals.
