Prefilled syringe is a single-use closed container packaging system used for packaging, storage and direct injection of injectable drugs. It has the functions of storing drugs and ordinary injection at the same time, and is a high-risk packaging container. This standard aims to standardize its naming and classification, production and manufacturing processes, production environment, packaging and storage, quality control and other life cycle elements. It becomes a common technical requirement for all aspects of production and use to ensure that the production of prefilled syringes is standardized and the quality is acceptable. control and reduce existing risks.