AAMI TIR17:2017/(R)2023

This technical information report provides guidance for health care product manufacturers in the qualification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide-ozone. Annexes address the specific sterilization modality concerns.