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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 14-334: ISO 15882 Second edition 2008-09-01, sterilization of health care products - chemical indicators - guidance for selection, use and interpretation of results. (Sterility)

Date of Standard: 2008. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Offices and Divisions associated with recognized standards:
Devices Affected:
Chemical indicators 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 with the following exceptions:

Classes of chemical indicator 4.4 Class 3: Single variable indicators is not recognized

Classes of chemical indicator 4.5 Class 4: Multi-variable indicators is not recognized

Classes of chemical indicator 4.6 Class 5: Integrating indicators is not recognized

Sections referencing Class 3, 4, and 5 are not recognized.
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
§880.2800 Indicator,Chemical,Enzymatic,Sterilization Process Class 2 MTC
Relevant Guidance:
"Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003"

"Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities: Draft Guide for Industry and FDA Reviewers, May 21, 2001

"Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions. October 4, 2007"
FDA Technical Contacts:
 Clarence Murray
  10903 New Hampshire Avenue WO66 RM2464
  Silver Spring MD 20993
  email: Clarence.Murray@fda.hhs.gov
 Steven Elliott
  10903 New Hampshire Avenue WO66 RM2565
  Silver Spring MD 20993
  email: Steven.Elliott@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