| ISO 11608-3 Second edition 2012-10-01 Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 6-294 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Elaine Mayhall FDA/OMPT/CDRH/ODE/DAGID/INCB/ 301-796-6301 Elaine.Mayhall@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 11608 is applicable to containers that are provided pre-filled, or that are to be filled by the user
with medicinal products intended by the manufacturer to be used with needle-based injection systems (NIS),
as covered by ISO 11608.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6920 | Introducer, Syringe Needle | Class 2 | KZH |
| §880.5860 | Injector, Pen | Class 2 | NSC |
| §880.5860 | Syringe, Antistick | Class 2 | MEG |
| §880.5860 | Syringe, Piston | Class 2 | FMF |
| §880.5860 | Syringe, Piston, Reprocessed | Class 2 | NKN |
| Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics Issued May 1999 Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 1993 |