Chemical characterization is the first step in the workflow used to establish the biological safety of medical devices, as required by ISO 10993.
Many compounds are intentionally added during the manufacture of a device, including colorants, plasticizers, impact modifiers, and processing aids. Others may be picked up inadvertently during processing or result from a degradation reaction during sterilization or storage.
Important phases in your product development lifecycle that may require E&L assessments include:
- Developing new product design concepts
- Performing verification testing for your design history file
- Changing raw material suppliers
- Implementing design or manufacturing process change
