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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 013 FR Publication Date: 10/31/2005 

Part B: Supplementary Information

Recognition Number 6-129: ISO 594-2 Second edition 1998-09-01, conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - part 2: lock fittings. (General Plastic Surgery/General Hospital)

Date of Standard: 1998. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
All Luer Taper piston, syringes, & hypodermic single lumen needles
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
§880.5860 Syringe, Piston Class 2 FMF
Relevant Guidance:
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:
 Keith Marin
  10903 New Hampshire Avenue WO66 RM2567
  Silver Spring MD 20993
  email: keith.marin@fda.hhs.gov
 Scott A. Colburn
  10903 New Hampshire Avenue WO66 RM5514
  Silver Spring MD 20993
  email: scott.colburn@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036