Standards

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

Contact Us

Standards Expertise

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:

  • 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

ISO Standards

Let’s work together

Life Science Outsourcing prides itself on our role as partners in bringing medical innovations to life. That partnership forms the foundation of what sets us apart.