| ISO 11608-7 First edition 2016-08-01 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment |
| Recognition Date | 2016-09-21 |
| Recognition List | 045 |
| Recognition Number | 6-382 |
| 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 11608-7:2016 specifies particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments. It applies to devices intended for patient or caregiver administration of medicinal products to humans.
It covers requirements to allow for safe and correct handling of the NIS, including labelling, packaging, and instructions for use. It also includes requirements for training programs, if applicable.
It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments.
It does not address requirements for use of sharps containers by persons with visual impairments.
| 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 Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. Issued June 6, 2013. |