The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using literature research and chemical characterization tests when appropriate. Additionally, there has been considerable progress in the development and standardization of new in vitro test methods. New testing is available for gas pathway devices. Chemistry testing, toxicological risk assessment, and other written evaluations addressing biocompatibility have received wide acceptance. These alternative in vitro methods provide multiple benefits, including: less sample amount, less time required to perform the test, and reduced animal use.
- How can a risk-based approach be used to address biocompatibility
- How can material and chemical characterization be used to reduce testing burden
- Update on development of alternative in vitro testing methods for irritation and sensitization