ISO Health Care Product Sterilization Standards Adopted By AAMI

ANSI AAMI ISO Health Care Sterilization Standards

A health care product is not sterile unless it is free of microorganisms. Sterilization is assured with these products and their materials and components through chemical or physical means. Common sterilization methods include liquid chemicals, moist heat, dry heat, ethylene oxide gas, and radiation.

Numerous international standards developed and published by the International Organization for Standardization (ISO) specify guidelines for the various sterilization methods of medical equipment and devices. As ANSI is the U.S. member body to ISO, the United States takes an active role in the development of many of these standards. The Association for the Advancement of Medical Instrumentation (AAMI) administers this participation.

AAMI has also adopted these documents as American National Standards, which generally are unchanged. The following international sterilization standards have been adopted:

ANSI/AAMI/ISO 14160:2011 (R2016) – 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

ANSI/AAMI/ISO 14161:2009 (R2014) – Sterilization of health care products – Biological indicators – Guidance for the selection, use and interpretation of results

ANSI/AAMI/ISO 14937:2009 (R2013) – Sterilization of healthcare products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO 15882:2008 (R2013) – Sterilization of health care products – Chemical indicators – Guidance for selection, use and interpretation of results

ANSI/AAMI/ISO 17665-1:2006 (R2013) – Sterilization of health care products – Moist heat – Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO TIR17665-2:2009 (R2016) – Sterilization of health care products – Moist Heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1

ANSI/AAMI/ISO TIR17665-3:2014 (R2016) – 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

ANSI/AAMI/ISO 18472:2006 (R2015) – Sterilization of health care products – Biological and chemical indicators – Test equipment

ANSI/AAMI/ISO 20857:2010 (R2015) – 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 TIR11139:2006 – Sterilization of health care products – Vocabulary

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 (R2015) and A1:2013 – Sterilization of health care products-Radiation-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, 2ed and Amendment 1.

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 11138-1:2017 – Sterilization of health care products – Biological indicators – Part 1: General requirements

ANSI/AAMI/ISO 11138-2:2017 – Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes

ANSI/AAMI/ISO 11138-3:2017 – Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes

ANSI/AAMI/ISO 11138-4:2017 – Sterilization of health care products – Biological indicators – Part 4: Biological indicators for dry heat sterilization processes

ANSI/AAMI/ISO 11138-5:2017 – Sterilization of health care products – Biological indicators – Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

ANSI/AAMI/ISO 11140-1:2014 – Sterilization of health care products – Chemical indicators – Part 1: General requirements

ANSI/AAMI/ISO 11140-3:2007 (R2015) – Sterilization of health care products – Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test

ANSI/AAMI/ISO 11140-4:2007 (R2015) – Sterilization of health care products – Chemical indicators – Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration

ANSI/AAMI/ISO 11140-5:2007 (R2015) – Sterilization of health care products – Chemical indicators – Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs

ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microrganisms on products (You can read about this American National Standard in depth in our post on the Determination of a Population of Microrganisms on Products for Sterilization)

ANSI/AAMI/ISO 11737-2-2009 (R2014) – Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

As each of these American National Standards originated as international ISO documents, each reflects an existing ISO standard with the same numeral designation. If you’d like to find the international versions of these standards, please refer to the AAMI Glossary of Equivalent Standards and search the ANSI Webstore. This list also notes if there are any technical variations with the national adoptions.

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