The NF EN ISO 10 993 series of international standards, transposed into French law, specifies the tests for the biological evaluation of medical devices. 10993-1 sets out the general requirements; 10993-5 specifies the tests for in-vitro cytotoxicity; 10993-10 covers tests for irritation and delayed-type hypersensitivity. These 3 parts describe the precise, documented and approved methods for the tests that gel lubricants and cosmetics sold by Terpan Laboratories have passed.