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

ASTM Standards
- ASTM-D4169
- ASTM-D642
- ASTM-F1140
- ASTM-F1980
- ASTM-F17
- ASTM-D4728
- ASTM-D999
- ASTM-D6653
- ASTM-F1886
- ASTM-E171
- ASTM-F2096
- ASTM-D5276
- ASTM-D4332
- ASTM-F1929
- ASTM-F88

ISO Standards
