MEDICAL PACKAGE TESTING
Life Science Outsourcing has deep expertise in providing packaging testing that complies with all relevant industry standards and guidelines.
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