scope:

The focus of this document 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 AAMI Technical Information Report (TIR) relates to:

- assessment of change;

- evaluation of differences between radiation sources;

- assessment of sterilization and verification dose;

- assessment of maximum acceptable dose.

Certain aspects that might be important in transferring products to different radiation sterilization sources are outside the scope of this TIR. These include:

- evaluation of biocompatibility;

- toxicological risk assessment;

- irradiator radiation safety, exclusive of the potential for induced radioactivity;

- cost or financial considerations;

- supply chain risk management;

- regulatory filings.