Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-294: AAMI / ANSI ST40:2004/(R)2010, Table-top dry heat (heated air) sterilization and sterility assurance in dental and medical facilities, 2ed.. (Sterility)
Date of Standard: 2004/(R)2010. |
| 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: |
| ALL OFFICES AND DIVISIONS IN CDRH |
|
|
| Devices Affected: |
| All devices that can be sterilized by dry heat in medical or dental facilities |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
|
| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
| Complete standard and any annexes |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6870 |
Sterilizer, Dry Heat |
Class 2 |
KMH |
| |
|
| Relevant Guidance: |
| Supplement to ANSI/AAMI ST50:2004, Dry Heat (Heated Air) Sterilizers |
|
| 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 |
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