Typically, biocompatibility evaluation studies are performed in accordance to ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing.
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 June 16, 2016.
Both documents classify medical devices regarding their nature of body contact and contact duration, and lists the biological test methods applicable for the respective device category.
We can perform the following services:
Tests for sensitization
Tests for irritation and intracutaneous reactivity
United States Pharmacopeia (USP) biological reactivity tests
- ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing
- ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
We offer a full range of medical device testing and a comprehensive portfolio of certification services to support your needs. From design to aftermarket, our engineers can test the safety and help mitigate the risk for your medical devices.
Evaluation is one of the key steps in the medical device and laboratory equipment 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.
Best Practices for Chemical Characterization
Gain an understanding of the chemical characterization for your products and get an overview of the main analytical methods according to ISO 10993-1, -12 and -18.