ISO 13408-1:2023 医疗保健产品的无菌处理 第1部分：一般要求

标准编号：ISO 13408-1:2023

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：2023-08

标准范围

本文件规定了医疗保健产品无菌加工开发、验证和常规控制的工艺、计划和程序的一般要求，并提供了指导。本文件包括与无菌处理总体主题相关的要求和指导。ISO的其他部分给出了与除菌过滤、冻干、就地清洗（CIP）技术、就地灭菌（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导？13408系列。

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.

标准预览图