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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 14-332
Standard
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
Identical Adoption
ANSI AAMI ISO 11140-5:2007/(R)2012
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
Scope/Abstract
ISO 11140-5:2007 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.
Additionally, ISO 11140-5:2007 includes test methods and equipment used to meet these performance requirements.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
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 FDA Guidance and/or Supportive Publications*
Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, Issued December 2003.

ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Sreekanth Gutala
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-7007
  Sreekanth.Gutala@fda.hhs.gov
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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