Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity; (CEN EN ISO 10993-11: 1995)
|Publication Date:||1 January 1993|
|ICS Code (Laboratory medicine):||11.100|
This part of ISO 10993 specifies methodologies for the evaluation of the systemic toxicity potential of medical devices which release constituents into the body. In addition, it includes pyrogenicity testing.
The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachabes. It is intended that tests for extracts or leachabes be conducted by choosing appropriate extraction vehicles to yield a maximum extraction of leachable materials, in order to conduct biological testing.