MEDICAL PACKAGE TESTING

Standards

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

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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

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