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U.S. Department of Health and Human Services

Recognized Consensus Standards

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FR Publication Date: 01/30/2014 

Part B: Supplementary Information

USP 32:2009, biological indicator for ethylene oxide sterilization, paper carrier. (Sterility)
Address of Standards Development Organization:
 United States Pharmacopeial Convention, Inc. (USP)
  12601 Twinbrook Parkway
  Rockville, MD 20852
 
CDRH Office and Division associated with recognized standards:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
Biological indicators for monitoring ethylene oxide sterilization processes
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
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
§880.2800 Indicator, Biological Sterilization Process Class 2 FRC
Relevant Guidance:
USP 32:2009 <55> BIOLOGICAL INDICATORS -- RESISTANCE PERFORMANCE TESTS

USP 32:2009 <1035> BIOLOGICAL INDICATORS FOR STERILIZATION

Guidance for Industry and FDA Staff; Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
FDA Technical Contact:
 Anne D. Lucas
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 64, Room 4010
  Silver Spring MD 20993
  301/796-0283
  email: anne.lucas@fda.hhs.gov
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