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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 6-11
Standard
ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
Scope/Abstract
Specification of the requirements for conical (Luer) fittings for use with hyperdemic syringes and needles and with certain other apparatus for medical use such as transfusion and infusion sets. It covers fittings made of rigid and semi-rigid materials and includes test methods for gauging and performance. It excludes provision for more flexible or elastomeric materials. The annex on liquid leakage is given as an example.
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
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§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

Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes. Issued April 1993

Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features. Issued August 9, 2005
FDA Technical Contacts
 Scott A. Colburn
  FDA/OC/CDRH/OSPTI/DAHRSSP/SCAP/
  301-796-6287
  scott.colburn@fda.hhs.gov
 Keith Marin
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-2462
  keith.marin@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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