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Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 14-195: AAMI / ANSI / ISO 11140-1:2005(R)2010, sterilization of health care products - chemical indicators - part 1: general requirements. (Sterility)

Date of Standard: 2005. 
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 Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Chemical indicators intended for use by health care facilities
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard with the following exceptions:

Classification 4.4 Class 3: Single variable indicators is not recognized

Classification 4.5 Class 4: Multi-varaiable indicators is not recognized

Classification 4.6 Class 5: Intergrating indicators is not recognized

Sections referencing Class 3, 4, and 5 are not recognized.
Related CFR Citations and Product Codes:
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 Guidance:
"Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003"

"Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions. October 4, 2007"
FDA Technical Contact:
 Geetha C. Jayan, M.V.Sc, Ph.D
  FDA/CDRH/OCD
  10903 New Hampshire Avenue Building 66, Room 3622
  Silver Spring MD 20993
  301/796-6300
  email: geetha.jayan@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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