ISO 11040-6:2019 预充式注射器 第6部分：注射用塑料桶和消毒的分管式注射器

标准编号：ISO 11040-6:2019

中文名称：预充式注射器 第6部分：注射用塑料桶和消毒的分管式注射器

英文名称：Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

发布日期：2019-01

标准范围

本文件规定了材料、尺寸、质量和性能要求，以及一次性使用的聚合物桶和消毒分装配注射器的试验方法。本文件还规定了作为灭菌分组件注射器的一部分，准备填充的部件。根据本文件准备好充装的聚合物桶和消毒分组件注射器仅供一次性使用。本文件未规定用于完成分组件注射器的部件，如柱塞和杆。预填充注射器可以在专用和专门设计的加工设备上生产，如在线成型和填充。本文件不适用，但也可用于此类专用预充注射器。

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.This document also specifies those components that are part of the sterilized subassembled syringe ready for filling.Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document.Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

标准预览图