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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 14-336
Standard
ISO  14161 Second edition 2009-09-15
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
Identical Adoption
ANSI AAMI ISO 14161-2009/(R)2014
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
Scope/Abstract
ISO 14161:2009 provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
ISO 14161:2009 applies to biological indicators for which International Standards exist.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 12.3 Incubation period Clause 12.3.3
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.

Section 12.3 Incubation period clause 12.3.3 is in conflict with an existing published final guidance, see Attachment II "Examples of Validation of Biological Indicator Incubation Time" of the guidance listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.2800 Indicator, Biological Sterilization Process Class 2 FRC
880.2805 Biological Sterilization Process Indicator With Recombinant-Dna Plasmid Class 2 OWP
Relevant FDA Guidance and/or Supportive Publications*
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
 Ramesh K. Panguluri
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6303
  ramesh.panguluri@fda.hhs.gov
 Christopher Dugard
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  240-402-6031
  christopher.dugard@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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