Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-195: AAMI / ANSI / ISO 11140-1:2005(R)2010, Sterilization of health care products - Chemical indicators - Part 1: General requirements. (Sterility)
Date of Standard: 2005. |
| 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) | | |
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| Devices Affected: |
| Chemical indicators intended for use by health care facilities |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
(Note: Three types of chemical indicators are cleared by the FDA - Process indicators, Chemical integrators and Air removal indicators for test pack. Unlike the ISO chemical indicator classes, FDA does not use numerical classes to designate chemical indicators. Performance characteristics specified for the following ISO Chemical Indicator classes are recognized by FDA.)
Recognized for Class 1: Process indicators
Recognized for Class 2: Specific test indicators
Recognized for Class 6: Emulating indicators; performance characteristics should be demonstrated to be equivalent to a legally marketed predicate device
In addtion, provide athe following data:
1. Resistometer testing for chemical indicators
2. Emulating indicators (Class 6):
a. Side-by-side (same chamber) testing of emulating indicators with appropriate biological indicators (BIs). FDA recommends that the resistance characteristics of the BIs be consistent with minimum performance characteristics described in the guidance "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions. October 4, 2007
b. Characterization of performance by varying only one parameter at a time.
3. Testing in an actual sterilizer used in health care facility.
4. Shelf life testing and stability testing of end-point color reaction for all chemical indicators.
5. Data showing that the endpoint specifications for all chemical indicators correlate with standard sterilization cycles used in health care facilities. |
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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 |
| §880.2800 |
Indicator,Chemical,Enzymatic,Sterilization Process |
Class 2 |
MTC |
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| Relevant Guidance: |
"Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003"
"Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions. October 4, 2007"
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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 3622 |
| Silver Spring MD 20993 |
| 301/796-6300 |
| Email: geetha.jayan@fda.hhs.gov |
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