ISO 11040-8:2016 预灌封注射器 第8部分：预装注射器的要求和测试方法

标准编号：ISO 11040-8:2016

中文名称：预灌封注射器 第8部分：预装注射器的要求和测试方法

英文名称：Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes

发布日期：2016-11

标准范围

ISO 11040-8:2016适用于基于ISO 11040-4或ISO 11040-6以及ISO 11040-5的无菌灌装或最终灭菌成品预灌装注射器（仅供一次性使用），适用于注重质量、功能性能和安全要求的肠外注射制剂，以及相关试验方法。注射前由用户进行额外准备步骤的成品预充注射器（例如，为重组而排空的稀释注射器，以及重组后吸入的重组药物溶液）不在ISO 11040的范围内-8:2016.

ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040？4 or ISO 11040？6, together with ISO 11040？5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.

标准预览图