ISO 10993-23: The Step-Wise Approach To Evaluate Potential Irritants In Medical Devices Becomes Effective
By Silvia Georges, Ph.D., NSF PROSYSTEM, an NSF International Company
The evaluation of biological safety is one important piece of the puzzle to demonstrate the safety of a medical device. Commonly, manufacturers make use of the ISO 10993 series of standards to assess the potential biological risks of their medical devices. Until recently, this series consisted of 21 standards, including technical reports and specifications, developed by the ISO Technical Committee 194,
Biological and clinical evaluation of medical devices (ISO/TC 194). In January 2021, the long-awaited new member in the family – ISO 10993-23:2021,