ISO 13408-5:2006 医疗保健产品的无菌处理 第5部分：就地灭菌

标准编号：ISO 13408-5:2006

中文名称：医疗保健产品的无菌处理 第5部分：就地灭菌

英文名称：Aseptic processing of health care products — Part 5: Sterilization in place

发布日期：2006-11

标准范围

ISO 13408-5:2006规定了通过无菌处理制造无菌医疗保健产品所用设备的产品接触表面的就地灭菌（SIP）一般要求，并提供了鉴定、验证、操作和控制指南。ISO 13408-5:2006适用于将杀菌剂输送到可能接触产品的设备内表面的过程。

ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

标准预览图