Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-290: AAMI / ANSI ST24:1999/(R) 2009, Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.. (Sterility)
Date of Standard: 1999/(R)2009. |
| 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 |
| |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
| Ethylene oxide sterilizers used in health care facilities |
|
| 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 |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6860 |
Sterilizer, Ethylene-Oxide Gas |
Class 2 |
FLF |
| |
|
| Relevant Guidance: |
Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, March, 1993
Addendum to Sterilizer Guidance Document, September 19, 1995 |
|
| FDA Technical Contact: |
| Steven Turtil |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1570 |
| Silver Spring MD 20993 |
| 301/796-6305 |
| Email: steven.turtil@fda.hhs.gov |
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