Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-314: AAMI / ANSI ST67:2011, Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile". (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
American National Standards Institute (ANSI)
25 West 43rd Street
4th Floor
New York, NY 10036
CDRH Office and Division Associated with Recognized Standards:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
All devices that need to be sterilized
Processes Affected:
510(K), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
National, Horizontal
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Relevant Guidance:
National and International standards for specific sterilization processes:
ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products-Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilzation process for medical devices
ANSI/AAMI/ISO 11137-1:2006/(R)2010, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ANSI/AAMI/ISO 11137-3:2006/(R)2010, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ANSI/AAMI/ISO 20857:2010, Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11135-2:2008, Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
ANSI/AAMI/ISO 17665-1: 2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and control of a sterilization process for medical devices
ANSI/AAMI/ISO TIR 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1:2006