ISO 6009 Fourth edition 2016-08-01

Standard Organization:

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

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§880.5570	Needle, Hypodermic, Single Lumen	Class 2	FMI

FDA Guidance:

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.