本技术信息报告为描述辐射特性提供了额外的指导 并建立必要的过程控制，以确保辐照系统 处于有效状态。本文件旨在补充资格认证和常规控制 ANSI/AAMI/ISO 11137中定义的伽马、X射线和电子束灭菌活动。

This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state. This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization.