辐射灭菌验证和常规操作手册：辐射

English | 168 pages | CRC Press; 1 edition (April 4, 2001) | 1587160579 | scan PDF | 5.48 Mb

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.

Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

生物材料和医疗器械的验证及辐射灭菌过程需要精心规划以确保符合监管要求，随后执行过程中需保持精确性并做好记录。这份详尽指南涵盖了从预验证计划到最终报告以及持续监控与控制的所有步骤。辐射灭菌验证操作手册：该指导书详细介绍了辐射灭菌验证和常规运行的整个过程。提出的建议遵循了ANSI/AAMI/ISO 11137:1994《医疗保健产品消毒-验证及例行控制要求-辐射灭菌》和新发布的AAMI对25 kGy使用VDmax程序的证实。作者讨论了帮助理解这些标准要求的方法，同时也提供了具体伽马射线和电子束辐射灭菌过程的验证和常规监控与控制实用步骤。 背景章节提供了有关辐射灭菌技术、消毒微生物学、验证方法以及与辐射灭菌承包商合作所需的信息。本书中的许多信息以便捷的表格和图表形式呈现，并配有一些简明易懂的示意图和其他图示，简单说明了适当的验证方法。辐射灭菌验证操作手册：该书将分散在多份文件中的一整套信息整合到一起，对所有涉及医疗材料、药品及设备消毒的人们都具有实用性。

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