| ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables |
| Recognition Date | 2012-08-20 |
| Recognition List | 029 |
| Recognition Number | 6-278 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Patricia Beaston FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-3155 patricia.beaston@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5860 | Injector, Pen | Class 2 | NSC |
| §880.5860 | Syringe, Antistick | Class 2 | MEG |
| §880.5860 | Syringe, Piston | Class 2 | FMF |
| §880.5570 | Needle, Hypodermic, Single Lumen | Class 2 | FMI |
| FDA Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes |