ISO 13408-6:2005 健保产品的防腐处理-第6部份： 隔离系统

标准编号：ISO 13408-6:2005

中文名称：健保产品的防腐处理-第6部份： 隔离系统

英文名称：Aseptic processing of health care products — Part 6: Isolator systems

发布日期：2005-06

标准范围

ISO 13408-6:2005规定了用于无菌处理的隔离器系统的要求，并提供了用于医疗保健产品无菌处理的隔离器系统的鉴定、生物去污、验证、操作和控制指南。ISO 13408-6:2005侧重于使用隔离器系统来维持无菌条件；这可能包括危险材料的应用。ISO 13408-6:2005不取代或取代国家监管要求，例如与国家或地区管辖区有关的良好生产规范（GMP）和/或药典要求。

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

标准预览图