AAMI updates sterilization materials compatibility guidance

Editor's Note

The Association for the Advancement of Medical Instrumentation (AAMI) has released the updated AAMI TIR17:2024; Compatibility of Materials Subject to Sterilization, its first revision since 2017. This guidance provides essential information for medical device manufacturers, designers, and sterilization professionals on how sterilization methods impact materials and packaging.

Updates include:

• Expanded modalities. The document covers traditional methods like ethylene oxide (EO) and newer alternatives such as chlorine dioxide, nitrogen dioxide, vaporized hydrogen peroxide, moist and dry heat, and radiation.
• Material interaction data. Novel scientific data now detail how 70 material types, including polymers, ceramics, and metals, interact with different sterilization modalities.
• Revised compatibility ratings. A comprehensive update to material compatibility table annexes, now using defined criteria supported by traceable data.
• Guidance on modalities. Clear recommendations for switching sterilization methods and designing real-time and accelerated aging programs to ensure product safety and longevity.

The guidance also addresses material selection, processing, and testing, helping prevent processing errors and ensuring the functionality and safety of sterilized products.