Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-296: AAMI / ANSI / ISO 11138-1:2006/(R)2010, Sterilization of health care products - Biological indicators - Part 1: General requirements. (Sterility)
Date of Standard: 2006. |
| 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 Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF COMPLIANCE (OC) | | DIVISION OF ENFORCEMENT A (DOEA) |
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| Devices Affected: |
| Biological indicators intended for use by health care facilities for monitoring sterilization processes |
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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 except for sections referencing ISO 13485:2003. FDA requires medical device manufacturers to comply with the Code of Federal Regulations (CFR), 21 CFR Part 820 Quality System Regulation and therefore does not require compliance with ISO 13485 for the establishment of a Quality Management System. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.2800 |
Indicator, Biological Sterilization Process |
Class 2 |
FRC |
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| Relevant Guidance: |
USP 35-NF30:2012 Biological Indicators for Sterilization
USP 35-NF30:2012 Biological Indicators - Resistance Performance Tests
Guidance for Industry and FDA Staff; Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
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| FDA Technical Contacts: |
| Cesar Perez, Ph.D. |
| FDA/CDRH/OC |
| 10903 New Hampshire Avenue Building 66, Room 1561 |
| Silver Spring MD 20993 |
| 301/796-5476 |
| Email: cesar.perez@fda.hhs.gov |
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| 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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