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AAMI TIR17:2017 (R2020)

Compatibility of materials subject to sterilization

This technical information report provides guidance for health care product manufacturers in thequalification 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.

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Association for the Advancement of Medical Instrumentation [aami]

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