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.
Package Testing Standards Organizations
Life Science Outsourcing is experienced in package testing that must comply with the following standards:
American National Standards Institute
Association for the Advancement of Medical Instrumentation
American Society for Testing & Materials
International Organization for Standardization
International Safe Transit Association