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 Medical Package Testing

ISTA Standards

ISO Medical Package Testing

ISO Standards

Life Science Outsourcing, Inc.

Other Standards