Radiation Sterilization Sterigenics（辐射灭菌Sterigenics）.pdfVIP

Guidelines for Validation Radiation Sterilization The Global Leader In Contract Sterilization Services AN OVERVIEW The radiation sterilization standards document, 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, incorporates methodologies of both ISO (International Standards Organization) and ANSI (American National Standards Institute). Further, it confirms agreement between the international standards for medical device sterilization and the guidelines for Gamma and Electron Beam Radiation previously followed by U.S. device manufacturers. The purpose of the validation process is to make certain products are rendered free of viable microorganisms, and thus, are “sterile.” The standards ensure certain predetermined criteria that validate sterilization are met prior to the production of a sterile healthcare product. These criteria include: q Evaluation of materials to be used in the product and its packaging CORPORATE HEADQUARTERS: q Determination of the product’s radiation stability