| ISO 11608-1 Third edition 2014-12-15 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 6-341 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Mary Brooks FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6078 Mary.Brooks@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 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.
| 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 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 Issued June 2013 Draft Guidance for Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO)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 |