本文件适用于基于ISO 11040-4或ISO 11040-6中规定的注射器筒组件的无菌处理或最终灭菌的成品预充式注射器（仅供一次性使用），以及基于ISO 11040-5中规定的组件的柱塞塞（密封后端）和用于肠胃外制剂的前端封盖，重点关注质量、功能性能和安全性要求以及相关检测方法。 使用者在注射前进行了额外制备步骤的成品预充式注射器（例如，含稀释剂的注射器已被清空以进行复溶，并且其中复溶的可注射产品在复溶后已被抽吸）不在本文件的范围内。 注1本文件也可用作其他类型、设计和/或尺寸成品预充式注射器的指南，例如双腔室预充式注射器。注2对于针头注射系统中使用的成品预充式注射器，另见ISO 11608（所有部件）。 注3请注意适用的国家或地区法规和药典，如欧洲药典。[2]、USP[3]或JP[4]。 注4作为医疗器械或根据产品的主要作用方式（即产品实现其主要预期作用的手段）介于医疗器械和药品之间的非处方预充式注射器成品属于本文件的范围，即使它们并不总是作为药品进行监管。

This document is applicable to aseptically processed or terminally sterilized finished prefilled syringes (intended for single use only) based on syringe barrel components addressed in ISO 11040-4 or ISO 11040-6, together with a plunger stopper (sealing the back end) based on components addressed in ISO 11040-5 and a front end closure for parenteral 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-containing syringes that have been emptied for reconstitution and in which the reconstituted injectable product has been aspirated after reconstitution) are excluded from the scope of this document.

NOTE 1        This document can also be used as a guidance for other types, designs and/or sizes of finished prefilled syringes, for example dual chamber prefilled syringes.

NOTE 2        For finished prefilled syringes that are used in needle-based injection systems, see also ISO 11608 (all parts).

NOTE 3        Attention is drawn to applicable national or regional regulations and pharmacopoeias, such as Ph.Eur. [2], USP [3] or JP [4].

NOTE 4        Finished prefilled syringes for parenteral preparations which are medical devices or which, according to the principal mode of action of the product (i.e. the means by which the product achieves its principal intended action), are borderline between medical devices and medicinal products fall within the scope of this document, even if they are not always regulated as medicinal products.