Medical Device Biocompatibility Testing

ISO 10993 and its role in device biocompatibility

Typically, biocompatibility evaluation studies are performed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

With regard to a U.S. Food and Drug Administration (FDA) registration of the device, further tests may be necessary as specified in the FDA guidance document “Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” issued on Sept 4, 2020.

Both documents classify medical devices regarding their nature of body contact and contact duration and list the biological endpoints/test methods applicable for the respective device category.

Our toxicity and biocompatibility testing services

We offer the following services:

• ISO 10993-18 – Chemical Characterization
• ISO 10993-17 – Toxicological Risk Assessment
• ISO 10993-5 – Test for in vitro cytotoxicity
• ISO 10993-10 – Tests for skin sensitization
• ISO 10993-23 – Tests for irritation
• ISO 10993-11 – Tests for systemic toxicity
• ISO 10993-3 – Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-6 – Tests for local effects after implantation
• United States Pharmacopeia (USP) biological reactivity tests
• ISO 10993-4 – Tests for interactions with blood (Hemocompatibility)
• ISO 10993-11 – Material mediated pyrogenicity (pyrogen testing)
• And others

Why UL Solutions

We offer a full range of medical device testing services to support your needs. From design to aftermarket, our scientists and toxicologists can help you demonstrate safety and mitigate the risk for your medical devices.

Evaluation is one of the key steps in the medical device life cycle, and we can help you evaluate your medical devices in accordance with national and global standards. Our familiarity with these standards makes for a seamless and trustworthy evaluation process.

• We have a strong team of professionals in diversified domains, building on our 25 years of expertise in non-clinical medical device testing.
• We have experience working with multiple regulatory bodies worldwide.
• Our senior toxicologists are American board-certified.
• Our scientists participate in developing the standards related to ISO 10993, ISO 18562 and more.
• We have a presence in more than 100 countries.

Related standards and references

• ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• History and Points of Revision of JIS T0993-1
• Special Considerations for 510(k)s