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
ISTA Standards

ISTA Standards

ISO Standards

ISO Standards

Other Standards

This information was provided by Medical Package Testing, a Division of Life Science Outsourcing, Inc. For more information visit