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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 14-332: ISO 11140-5 Second edition 2007-03-15, sterilization of health care products - chemical indicators ? part 5: class 2 indicators for bowie and dick-type air removal tests . (Sterility)

Date of Standard: 2007. 
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:
ALL OFFICES AND DIVISIONS IN CDRH
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:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§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

ISO 15882 Second edition 2008-09-01 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
  FDA/CDRH/OCD
  10903 New Hampshire Avenue Building 66, Room 3622
  Silver Spring MD 20993
  301/796-6300
  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
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