| ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification. |
| Recognition Date | 2016-09-21 |
| Recognition List | 045 |
| Recognition Number | 6-381 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Oleg Vesnovsky FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2527 oleg.vesnovsky@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 6009:2016 establishes a colour code for the identification of single-use hypodermic needles of designated metric in the range of 0,18 mm (34 Gauge) to 3,4 mm (10 Gauge) . It applies to regular-walled, thin-walled, extra-thin-walled and ultra-thin walled needles, and to opaque and translucent colours.
It is not applicable to pen-needles.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5570 | Needle, Hypodermic, Single Lumen | Class 2 | FMI |
| Safely Using Sharps (Needles and Syringes) at Home, at Work and on Travel. Issued March 3, 2016. 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. Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]. Issued July 11, 2008. Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles. Issued April 1, 1993. |