scope:

This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma, electron beam, and X-ray sterilization.

NOTE-This TIR is intended to be used in conjunction with ANSI/AAMI/ISO 11137-1, Sterilization of health care products-- Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Because a TIR is considered "informative" and is not subject to the same formal approval process as a standard, the process steps are described in the TIR as "should" rather than "shall." Readers are reminded that many of this TIR's "shoulds" are "shalls" in ANSI/AAMI/ISO 11137-1.