Package Testing Standards

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