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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 14-358: AAMI / ANSI / ISO 14160:2011, 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. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
ALL OFFICES AND DIVISIONS IN CDRH
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:
 International, Vertical
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:
Regulation
Number
Device Name Device
Class
Product
Code
§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

AAMI/ANSI ST58:2005, Chemical sterilization and high-level disinfection in health care facilities
FDA Technical Contact:
 Elaine Mayhall, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2612
  Silver Spring MD 20993
  301/796-6301
  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
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