Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-219: AOAC 6.3.06:2008, Official Method 965.12, Tuberculocidal Activity of Disinfectants. (Sterility)
Date of Standard: 2008. |
| Address of Standards Organization: |
| AOAC International (AOAC) |
| 481 North Frederick Avenue |
| Suite 500 |
| Gaithersburg, MD 20877-2417 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
|
| (3) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
|
|
| Devices Affected: |
| Liquid chemical sterilants (high level disinfectants), general purpose disinfectants |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
|
| Type of Standard: |
| National, Vertical |
| 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
ANSI/AAMI ST58:2005/(R)2010, Chemical sterilization and high-level disinfection in health care facilities |
|
| FDA Technical Contact: |
| Denise Hampton, Ph.D |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2252 |
| Silver Spring MD 20993 |
| 301/796-6860 |
| Email: denise.hampton@fda.hhs.gov |
|
|
