GSO ISO 11040-6:2013

Prefilled syringes - Part 6: Plastic barrels for injectables


 

 

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标准号
GSO ISO 11040-6:2013
发布
2013年
发布单位
GSO
当前最新
GSO ISO 11040-6:2013
 
 
适用范围
This part of ISO 11040 specifies the materials, dimensions and requirements for plastic barrels (single-chamber 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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