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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 6-278: ISO 11040-5 Third edition 2012-02-15, prefilled syringes - part 5: plunger stoppers for injectables. (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:
All medical device glass barrels used in the delivery of parenteral pharmaceutical products
Processes Affected:
510(k), PMA, IDE, Pre-IDE, HDE, GMP, Design Controls
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 Injector, Pen Class 2 NSC
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
Relevant Guidance:
FDA Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes
FDA Technical Contact:
 Patricia Beaston
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2536
  Silver Spring MD 20993
  301/796-3155
  email: patricia.beaston@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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