ISO 13408-6:2005规定了用于无菌加工的隔离器系统的要求，并提供有关保健产品无菌加工的隔离系统的鉴定，生物去污，验证，操作和控制的指导。 ISO 13408-6:2005着重于使用隔离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不会取代或替代国家监管要求，如良好生产规范（GMP）和/或与国家或地区管辖范围有关的特殊要求

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.