AAMI
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The Association for the Advancement of Medical Instrumentation (AAMI) has published AAMI TIR17:2024; Compatibility of materials subject to sterilisation. Last updated in 2017 to address an urgent need for information sharing, AAMI TIR17 is relevant to medical device manufacturers, product designers, and sterilisation professionals.
TIR17 applies to new alternatives to ethylene oxide (EO) like chlorine dioxide and vaporised hydrogen peroxide, and addresses the selection and qualification of polymers, ceramics, and metals subject to sterilisation. The guidance features:
- Information on modalities like ethylene oxide (EO), nitrogen dioxide, vaporised hydrogen peroxide, moist and dry heat, radiation, and more.
- Novel scientific data on how these modalities interact with seventy unique material types.
- Detailed guidance on modality switching and real-time and accelerated ageing programs.
Jami McLaren, PhD, Sterility Assurance Fellow at Boston Scientific, co-chair of AAMI’s Compatibility of Materials Subject to Sterilisation Working Group said: “The most significant change in the new revision of AAMI TIR17 is the complete revision of the material compatibility table annexes. These annexes were revised with new compatibility ratings based on defined criteria to reference valid and traceable data that supports the rating.”
McLaren continued: “Compatibility of materials in sterilised products is a critical aspect of successful device development. AAMI TIR17 provides valuable information on aspects of several sterilisation modalities that can impact material compatibility and how medical device materials interact with these modalities.”
TIR17 also addresses:
- Material selection: Addressing each sterilisation modality and choosing compatible materials.
- Material processing: Optimising material performance to avoid processing errors and negative results.
- Material testing: Assessing the product and packaging for functionality and safety after sterilisation and ageing.
- Accelerated ageing programs: Ensuring correlation with real-time ageing while reducing cost and time required.
