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
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.
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