For medical devices with direct or indirect patient contact, the biological safety of the device and its intended use should be considered. Typically, biocompatibility evaluation studies are performed, where necessary, in accordance to ISO 10993-1:2009 “Biological evaluation of medical devices – Part 1: Evaluation and testing”. With regard to an US 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. However, the tables showing the applicable biological test methods should not be used as a check box.
Potential tests can include many different variations and be divided into In-Vitro and In-Vivo tests.
- Cytotoxicity Testing
- Tests for Sensitization
- Tests for Irritation and Intracutaneous Reactivity
- Systemic Toxicity
- Genotoxicity Testing
- Implantation Tests
- USP Biological Reactivity Tests
- Hemocompatibility Testing
- Pyrogen Testing
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