本文件规定了卫生保健产品无菌加工的开发、验证和常规控制过程、程序和程序的一般要求，并提供了指导。 本文件包括与无菌处理整体主题相关的要求和指南。 ISO 13408系列的其他部分给出了与杀菌过滤、冷冻干燥、原位清洗（CIP）技术、原位杀菌（SIP）和隔离器系统相关的各种专业工艺和方法的具体要求和指南。

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