标准摘要
[中文适用范围]： ISO 13408 的这一部分规定了工艺模拟的替代方法的要求并提供了指导，以验证无法最终灭菌且无法应用 ISO 13408-1 的工艺模拟方法的医疗器械和组合产品的无菌加工资格。 ISO 13408 的这一部分描述了在无菌工艺开发过程中如何使用风险评估来设计医疗器械和组合产品的工艺模拟研究，在无菌工艺过程中直接用介质替代产品不可行或无法实现的情况下。 不模拟实际的无菌过程。 [外文原描述]： ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.
英文名称Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products