| ISO 11608-5 First edition 2012-10-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function. |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 6-377 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Alan Stevens FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6294 alan.stevens@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 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.
| 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 and FDA Staff: Technical Consideration for Pen. Jet, and Related Injectors Intended for Use with Drugs and Biological Products. Issued June 2013. Draft Guidance for Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4. Issued April 2013. Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 1993. |