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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 063 Date of Entry 09/09/2024 
FR Recognition Number 14-460
Standard
ISO  11140-1 Third edition 2014-11-01
Sterilization of health care products - Chemical indicators - Part 1: General requirements
Identical Adoption
ANSI AAMI ISO 11140-1:2014
Sterilization of health care products - Chemical indicators - Part 1: General requirements
Scope/Abstract
ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
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
§880.2800 Indicator, Chemical, Enzymatic, Sterilization Process Class 2 MTC
Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff, Issued December 2003.

Biological Indicator (BI) Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, Issued October 2007.

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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