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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 6-11: ISO 594/1, conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - part 1: general requirements. (General Plastic Surgery/General Hospital)

Date of Standard: 1986. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
All luer taper pistons syringes & hypodermic single lumen needles
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
§880.5860 Syringe, Antistick Class 2 MEG
§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 Contact:
 Scott A. Colburn
  FDA/CDRH/OCD
  10903 New Hampshire Avenue Building 66, Room 3628
  Silver Spring MD 20993
  301/796-6287
  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
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