AAMI ISO 11607 : 2ED 2000

Defines requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices, whether produced industrially or in health care facilities. Also includes the principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical devices and requirements for essential criteria used to evaluate the performance of the package used to protect device components during handling, distribution, and storage.