Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-358: AAMI / ANSI / ISO 14160:2011, Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices. (Sterility)
Date of Standard: 2011. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
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| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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| 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: |
| Single-use medical devices incorporating materials of animal origin |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Quality System Regulation |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
Complete standard and any annexes except for the following:
FDA does not recognize ISO 22442-3.
FDA does not recognize sections regarding parametric release, including Sections 10.4, 11.1.1, 12.3.4, and A 9.1. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6885 |
Sterilant, Medical Devices |
Class 2 |
MED |
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| Relevant Guidance: |
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants, January 3, 2000
AAMI/ANSI ST58:2005, Chemical sterilization and high-level disinfection in health care facilities |
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| FDA Technical Contact: |
| 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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