Prefilled syringes-Glass barrels for injectables and sterilized subassembled syringes ready for filling
预充注射器
发布日期:
2020-03-09
ISO 11040的本部分适用于
-用于注射制剂的玻璃管筒(单室设计),以及准备填充的消毒分组件注射器。
它规定了材料、尺寸、质量和性能要求,以及相关的测试方法。
ISO 11040的这一部分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ISO 11040本部分的规定,准备好填充的玻璃桶和消毒过的分组件注射器仅供一次性使用。交叉引用:ISO 21748:2017ISO 7864ISO 7886-1:2017ISO 80369-1:2018BS EN ISO 80369-1:2018ISO 10993-7ISO 80369-7ISO 11040-5ISO 720:1985ISO 4802-2ISO 9626ISO 4802-1ISO 8871-1ISO 2859-1ISO 11040-7ISO 11135-1ISO 11608-2ISO 554IN 13097-4ISO 14644-1ISO 10993-1ISO 11137ISO 15378ISO 14937-5ISO 11608-5GUM:1995ISO 527-2ISO 80369-7AAMI ST72:
2011ISO 23908ISO 11140ISO 2039-2ISO 180ISO 3951ISO 17665-1ISO/IEC指南98-3:2008 ISO 178ISO 7619-1包含以下内容:修订,2020年3月
This part of ISO 11040 applies to
— tubing-glass barrels (single-chamber design) for injection preparations, and— sterilized subassembled syringes ready for filling.
It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
This part of ISO 11040 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this part of ISO 11040 are intended for single use only.Cross References:ISO 21748:2017ISO 7864ISO 7886-1:2017ISO 80369-1:2018BS EN ISO 80369-1:2018ISO 10993-7ISO 80369-7ISO 11040-5ISO 720:1985ISO 4802-2ISO 9626ISO 4802-1ISO 8871-1ISO 2859-1ISO 11040-7ISO 11135-1ISO 11608-2ISO 554DIN 13097-4ISO 14644-1ISO 10993-1ISO 11137ISO 15378ISO 14937ISO 11608-5GUM:1995ISO 527-2ISO 80369-7AAMI ST72:2011ISO 23908ISO 11140ISO 2039-2ISO 180ISO 3951ISO 17665-1ISO/IEC Guide 98-3:2008ISO 178ISO 7619-1Incorporates the following:Amendment, March 2020