Complete Rewrite of ISO 10993-1 Creates Industry Buzz
Biological evaluation for all medical devices is conducted using guidance provided in ISO 10993-1, the overarching standard for this process. It is the document that gives the general framework for risk assessment and assists in the selection of appropriate biological endpoints for evaluation. It also describes how available information should be applied to determine the need for further testing. ISO 10993-1 is an important reference document for all medical devices…