| ISO 11608-4 First edtion 2006-03-15 Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 6-174 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Keith Marin FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-2462 keith.marin@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.
ISO 11608-4:2006 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance.
| 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 on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes, Issued April 1993 |