AAMI TIR29-2012辐照灭菌的过程控制指南.doc

Technical Information Report AAMI TIR29: 2012 Guide for process characterization and control in radiation sterilization of medical devices   AAMI Technical Information Report AAMI TIR29:2012 (Revision of AAMI TIR29:2002) Guide for process characterization and control in radiation sterilization of medical devices Approved 31 December 2012 Association for the Advancement of Medical Instrumentation Abstract: 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. Keywords: installation qualification, operational qualification, performance qualification, dose mapping, routine monitoring and control, irradiator validation, process effectiveness, gamma, electron beam, X-ray, e-beam  AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is n