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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 045 Date of Entry 09/21/2016 
FR Recognition Number 6-381
Standard
ISO  6009 Fourth edition 2016-08-01
Hypodermic needles for single use - Colour coding for identification.
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
Relevant FDA Guidance and/or Supportive Publications*
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.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Oleg Vesnovsky
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2527
  oleg.vesnovsky@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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