ISO10993
ISO 10993 is an international standard developed by the International Organization for Standardization (ISO) that provides guidelines for the biological evaluation of medical devices. The standard is designed to help manufacturers evaluate the potential biological risks associated with their devices and ensure their safety for use in the human body.
ISO 10993 is divided into 20 parts, each covering a specific aspect of biological evaluation. Part 1
The standard requires manufacturers to consider the biological evaluation of their devices throughout the design, development,
Use of ISO 10993 is optional but highly recommended by regulatory bodies, including the FDA in the