ANSI/AAMI/ISO 13408-5-2006 保健产品的无菌加工.第5部分:现场消毒

标准号：ANSI/AAMI/ISO 13408-5-2006
中文标准名称：保健产品的无菌加工.第5部分:现场消毒
英文标准名称：Aseptic Processing of health care products - Part 5: Sterilization in place
标准类型：C50
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C50
国际标准分类号：11.080.01
适用范围：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. This standard applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.