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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 040 Date of Entry 08/14/2015 
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
Partial recognition. The following part(s) of the standard is (are) not recognized:
Classification 4.4 Type 3: Single variable indicators
Classification 4.5 Type 4: Multi-variable indicators
Classification 4.6 Type 5: Integrating indicators
Section 13 Type 6: The Performance Testing
Sections referencing Types 3, 4, and 5
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.

FDA does not recognize these clauses because it does not satisfy a requirement under the FD&C Act and the requirement encompasses those indicators in commercial distribution for use by hospitals and health care facilities to verify and monitor their sterilization equipment.
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 Contact
 Clarence Murray
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-0270
  Clarence.Murray@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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