标准编号：ISO 13408-1:2008
中文名称：医疗保健产品的无菌处理 第1部分：一般要求
英文名称：Aseptic processing of health care products — Part 1: General requirements
发布日期：2008-06
标准范围
1.1 This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes,programmes and procedures for development, validation and routine control of the manufacturing process foraseptically-processed health care products.1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of asepticprocessing. Specific requirements and guidance on various specialized processes and methods related tofiltration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems aregiven in other parts of ISO 13408.NOTEThis part of ISO 13408 does not supersede or replace national regulatory requirements, such as GoodManufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regionaljurisdictions.
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