Both the FDA and international regulatory bodies emphasize on compliance with ISO 11607; Packaging for terminally sterilized medical devices. This standard defines the test requirements necessary to ensure that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport or storage.
MPT is experienced in package testing that must comply with the following standards:
- ANSI – American National Standards Institute
- AAMI – Association for the Advancement of Medical Instrumentation
- ASTM – American Society for Testing & Materials
- ISO – International Organization for Standardization
- ISTA – International Safe Transit Association