ISO 11040-5:2012
Prefilled syringes - Part 5: Plunger stoppers for injectables
- Standard No.
- ISO 11040-5:2012
- Release Date
- 2012
- Published By
- International Organization for Standardization (ISO)
- Latest
- ISO 11040-5:2012
- Scope
- Prefilled syringes — This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO 11040-4. Plunger stoppers specified in this part of ISO 11040 are intended for single use only. This part of ISO 11040 is not applicable to barrier-coated plunger stoppers. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
ISO 11040-5:2012 history
- 2012 ISO 11040-5:2012 Prefilled syringes - Part 5: Plunger stoppers for injectables
- 2001 ISO 11040-5:2001 Prefilled syringes - Part 5: Plungers for injectables
- 1996 ISO 11040-5:1996 Prefilled syringes - Part 5: Plungers for injectables
