ISO 11040-6:2012
Prefilled syringes - Part 6: Plastic barrels for injectables
- Standard No.
- ISO 11040-6:2012
- Release Date
- 2012
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 11040-6:2019
- Latest
- ISO 11040-6:2019
- Scope
- 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 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.
ISO 11040-6:2012 history
- 2019 ISO 11040-6:2019 Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
- 2012 ISO 11040-6:2012 Prefilled syringes - Part 6: Plastic barrels for injectables
