Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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045
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Date of Entry 09/21/2016
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FR Recognition Number
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6-381
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Standard | |
ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification. |
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Scope/AbstractISO 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. |
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Extent of Recognition
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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. |
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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 |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |