Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-238: AAMI / ANSI / ISO 11140-5:2007/(R)2012, Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal test sheets and packs. (Sterility)
Date of Standard: 2007. |
| 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 |
| |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Office and Division Associated with Recognized Standards: |
| ALL OFFICES AND DIVISIONS IN CDRH |
|
|
| Devices Affected: |
| Chemical indicators for air removal test sheets and packs intended for use by health care facilities |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
|
| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.2800 |
Indicator, Physical/Chemical Sterilization Process |
Class 2 |
JOJ |
| §880.2800 |
Indicator, Sterilization |
Class 2 |
LRT |
| |
|
| Relevant Guidance: |
Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff, December 19, 2003
ANSI/AAMI/ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
|
| FDA Technical Contact: |
| 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 |
|
|
