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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 034 Date of Entry 01/30/2014 
FR Recognition Number 14-334
Standard
ISO  15882 Second edition 2008-09-01
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
Identical Adoption
ANSI AAMI ISO 15882:2008/(R)2013
Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
Scope/Abstract
ISO 15882:2008 provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes.
ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators 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:
Classes of chemical indicator 4.4 Class 3: Single variable indicators
Classes of chemical indicator 4.5 Class 4: Multi-variable indicators
Classes of chemical indicator 4.6 Class 5: Integrating indicators
Sections referencing Class 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.

Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, Issued September 1995.

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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