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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 14-361: ISO 14160 Second edition 2011-07-01, sterilization of health care products - liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices. (Sterility)

Date of Standard: 2011. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Single-use medical devices incorporating materials of animal origin
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes except for the following:

FDA does not recognize ISO 22442-3.
FDA does not recognize sections regarding parametric release, including Sections 10.4, 11.1.1, 12.3.4, and A.9.1.
Related CFR Citations and Product Codes:
Device Name Device
§880.6885 Sterilant, Medical Devices Class 2 MED
Relevant Guidance:
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants, January 3, 2000

ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities
FDA Technical Contact:
 Elaine Mayhall
  10903 New Hampshire Avenue WO66 RM2612
  Silver Spring MD 20993
  email: Elaine.Mayhall@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036