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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-275: ISO 11608-2 Second edition 2012-04-01, needle-based injection systems for medical use - requirements and test methods - part 2: needles. (General Plastic Surgery/General Hospital)

Date of Standard: 2012. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Pen injectors, Auto-injectors
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5860 Injector, Pen Class 2 NSC
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§880.5860 Syringe, Piston, Reprocessed Class 2 NKN
§880.6920 Introducer, Syringe Needle Class 2 KZH
Relevant Guidance:
Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 1993
FDA Technical Contact:
 Jacqueline Ryan, M.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2556
  Silver Spring MD 20993
  301/796-9599
  email: jacqueline.ryan@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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