Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-181: AAMI / ANSI ST58:2005/(R)2010, Chemical sterilization and high-level disinfection in health care facilities. (Sterility)
Date of Standard: 2005. |
| 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: |
| Medical devices that are reprocessed using glutaraldehyde-based products |
|
| 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 |
| §880.6885 |
Sterilant, Medical Devices |
Class 2 |
MED |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6890 |
Disinfectant, Medical Devices |
Class 1 |
LRJ |
| |
|
| Relevant Guidance: |
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants, January 3, 2000
|
|
| 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 |
|
| 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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