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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 14-396: AAMI / ANSI ST77:2013, containment devices for reusable medical device sterilization. (Sterility)

Date of Standard: 2013. 
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
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Reusable rigid sterilization containers, instrument cases, cassettes, and organizing trays intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization.
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard with the following exceptions:

Section 4: Requirements
4.4.4.1 General Requirements [Sterility maintenance] is not recognized

Section 5 Tests
5.9.1.1 General [Sterility maintenance] is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.6850 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class 2 KCT
Relevant Guidance:
Premarket Notification [510(k) Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA
FDA Technical Contact:
 Steven Elliott
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2565
  Silver Spring MD 20993
  301/796-5285
  email: steven.elliott@fda.hhs.gov
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