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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 14-274: AAMI / ANSI / ISO 15882:2008, sterilization of health care products - chemical indicators - guidance for selection, use, and interpretation of results. (Sterility)

Date of Standard: 2008. 
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 Regulation
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard with the following exceptions:

Classes of chemical indicator 4.4 Class 3: Single variable indicators is not recognized

Classes of chemical indicator 4.5 Class 4: Multi-variable indicators is not recognized

Classes of chemical indicator 4.6 Class 5: Integrating 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"

"Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities: Draft Guide for Industry and FDA Reviewers, May 21, 2001

"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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