Description

AAMI TIR104 – Guidance on transferring health care products between radiation sterilization sources

The focus of TIR104 is to provide guidance in managing the process for transferring a health care product either from one radiation sterilization modality to another or from one irradiator to another using the same radiation modality. The specific radiation modalities addressed are gamma, electron beam, and X-ray.

Guidance in this TIR relates to: assessment of change; evaluation of differences between radiation sources; assessment of sterilization and verification dose; and assessment of maximum acceptable dose.