标准编号：ISO 11040-6:2012
中文名称：预灌封注射器 第6部分：注射剂用塑料管
英文名称：Prefilled syringes — Part 6: Plastic barrels for injectables
发布日期：2012-04
标准范围
This part of ISO 11040 specifies the materials, dimensions and requirements for plastic barrels (singlechamber design) for injection preparations, which are to be subsequently filled and assembled on standardized processing equipment.It is applicable to pre-filled plastic syringes intended for single use only.Pre-filled syringes can be produced on dedicated and specifically designed processing equipment. This part of ISO 11040 is not applicable to such dedicated pre-filled syringes.Before the final approval for human use is granted, compatibility tests applying the intended pharmaceuticals are carried out. This part of ISO 11040 does not specify the procedures for such compatibility tests.
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