ISO 13408-1:2008 医疗保健产品的无菌处理 第1部分：一般要求

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

ISO 13408-1:2008规定了无菌加工医疗保健产品制造过程的开发、验证和常规控制的一般要求，并提供了有关过程、计划和程序的指南。ISO 13408-1:2008包括与无菌处理整体主题相关的要求和指南。ISO 13408的其他部分给出了与过滤、冷冻干燥、就地清洗（CIP）技术、就地灭菌（SIP）和隔离器系统相关的各种特殊工艺和方法的具体要求和指南。

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

标准预览图