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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 6-293: ISO 23907 First edition 2012-09-01, sharps injury protection - requirements and test methods - sharps containers. (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)
DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Sharps Disposal Containers
Processes Affected:
510(k)
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5570 Container, Sharps Class 2 MMK
Relevant Guidance:
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers. Issued Ootober 1993
FDA Technical Contacts:
 Elaine Mayhall, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2612
  Silver Spring MD 20993
  301/796-6301
  email: elaine.mayhall@fda.hhs.gov
 Matthew Schwerin
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2216
  Silver Spring MD 20993
  301/563-9114
  email: matthew.schwerin@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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