Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-201: AAMI / ANSI ST77:2006/(R)2010, Containment devices for reusable medical device sterilization. (Sterility)
Date of Standard: 2006. |
| Addresses of Standards 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: |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
|
| 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| Premarket Notification [510(k) Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA |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 Contacts: |
| Geetha C. Jayan, M.V.Sc, Ph.D |
| FDA/CDRH/OCD |
| 10903 New Hampshire Avenue Building 66, Room 5400 |
| Silver Spring MD 20993 |
| 301/796-6300 |
| Email: geetha.jayan@fda.hhs.gov |
|
| 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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