Sterile devices are free of viable microorganisms. Regulatory requirements for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements have been supported by a portfolio of standards on:
- designating products as sterile
- validating and routinely controlling the sterilization process
- maintaining sterility over time with appropriate sterile barrier systems
This paper provides an overview of these regulatory requirements and the standards that support them.