ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization 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 [Including: Amendment 1 (2013)].
ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
ANSI/AAMI/ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
ANSI/AAMI/ISO 20857:2010/(R)2015, 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 17665-1:2006/(R)2013, 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.
ANSI/AAMI/ISO TIR 17665-3:2014, Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization.
| Myra Smith |
| FDA/OC/CDRH/OPEQ/OHTV/DHTVA/ |
| 301-796-6507 |
| Myra.Smith@fda.hhs.gov |
| ANSI | American National Standards Institute | https://www.ansi.org/ |
| AAMI | Association for the Advancement of Medical Instrumentation | http://www.aami.org |