Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-332: ISO 11140-5 Second edition 2007-03-15, Sterilization of health care products - Chemical indicators ? Part 5: Class 2 indicators for Bowie and Dick-type air removal tests . (Sterility)
Date of Standard: 2007. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| ALL OFFICES AND DIVISIONS IN CDRH |
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| Devices Affected: |
| Chemical indicators for air removal test sheets and packs intended for use by health care facilities |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Vertical, International |
| 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 |
| §880.2800 |
Indicator, Physical/Chemical Sterilization Process |
Class 2 |
JOJ |
| §880.2800 |
Indicator, Sterilization |
Class 2 |
LRT |
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| Relevant Guidance: |
Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff, December 19, 2003
ISO 15882 Second edition 2008-09-01 Sterilization of health care products ? Chemical indicators ? Guidance for selection, use and interpretation of results |
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| 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 |
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