Summary: AAMI has released TIR17:2024 on materials compatibility for device sterilization, updating guidance on ethylene oxide and new alternatives like chlorine dioxide and vaporized hydrogen peroxide. The revised annexes feature new compatibility ratings based on validated data, helping manufacturers select, process, and test materials while optimizing both real-time and accelerated aging programs.

Two Key Takeaways:

  • TIR17:2024 expands sterilization guidance with updated material compatibility data for multiple modalities, including emerging alternatives to ethylene oxide.
  • The revised annexes and aging program recommendations offer manufacturers a roadmap to ensure device safety and performance throughout sterilization and product life cycles.

The Association for the Advancement of Medical Instrumentation (AAMI) has published AAMI TIR17:2024; Compatibility of materials subject to sterilization. Last updated in 2017 to address an urgent need for information sharing, AAMI TIR17 is relevant to medical device manufacturers, product designers, and sterilization professionals.

Scope and New Alternatives

TIR17 applies to new alternatives to ethylene oxide (EO) like chlorine dioxide and vaporized hydrogen peroxide, and addresses the selection and qualification of polymers, ceramics, and metals subject to sterilization. The guidance features:

  • Information on modalities like ethylene oxide (EO), nitrogen dioxide, vaporized hydrogen peroxide, moist and dry heat, radiation, and more.
  • Novel scientific data on how these modalities interact with 70 unique material types.
  • Detailed guidance on modality switching and real-time and accelerated aging programs.

“The most significant change in the new edition of AAMI TIR17 is the complete revision of the material compatibility table annexes,” said Jami McLaren, PhD, Sterility Assurance Fellow at Boston Scientific and co-chair of AAMI’s Compatibility of Materials Subject to Sterilization Working Group. “These annexes were revised with new compatibility ratings based on defined criteria to reference valid and traceable data that supports the rating.”

RELATED: AAMI Updates Guidance on Chemical Sterilization

Additional Guidance and Considerations

TIR17 also addresses:

  • Material selection: Addressing each sterilization modality and choosing compatible materials.
  • Material processing: Optimizing material performance to avoid processing errors and negative results.
  • Material testing: Assessing the product and packaging for functionality and safety after sterilization and aging.
  • Accelerated aging programs: Ensuring correlation with real-time aging while reducing cost and time required.

“Compatibility of materials in sterilized products is a critical aspect of successful device development,” said McLaren. “AAMI TIR17 provides valuable information on aspects of several sterilization modalities that can impact material compatibility and how medical device materials interact with these modalities.”

Interested parties can purchase TIR17 on AAMI ARRAY or as part of an AAMI e-subscription.