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

Part B: Supplementary Information

Recognition Number 14-238: AAMI / ANSI / ISO 11140-5:2007/(R)2012, sterilization of health care products - chemical indicators - part 5: class 2 indicators for bowie and dick-type air removal test sheets and packs. (Sterility)

Date of Standard: 2007. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 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:
Chemical indicators for air removal test sheets and packs intended for use by health care facilities
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Device Name Device
§880.2800 Indicator, Physical/Chemical Sterilization Process Class 2 JOJ
§880.2800 Indicator, Sterilization Class 2 LRT
Relevant Guidance:
Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff, December 19, 2003

ANSI/AAMI/ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
FDA Technical Contact:
 Geetha C. Jayan, M.V.Sc, Ph.D
  10903 New Hampshire Avenue Building 66, Room 3622
  Silver Spring MD 20993
  email: geetha.jayan@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