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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 045 Date of Entry 09/21/2016 
FR Recognition Number 6-379
Standard
ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
Scope/Abstract
ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric s 0,18 mm to 1,2 mm.
It does not apply to those devices that are covered by their own standard such as dental needles and 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*
Guidance on the Content of Premarket Notification [510(k)] Submissions for Hypodermic Single Lumen Needles. Issued April 1993.
FDA Technical Contacts
 Keith Marin
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-2462
  keith.marin@fda.hhs.gov
 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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