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AAMI Standards

About the Association for the Advancement of Medical Instrumentation

The Association for the Advancement of Medical Instrumentation (AAMI) has a mission to lead global collaboration in the development, management and use of safe and effective health technology.

Based in the United States, the organisation has more than 11,000 members, including healthcare technology professionals, institutions and corporations. Its goal is to advance safety in the health technology industry and promote best practices in order to improve patient care.

AAMI is the primary source of national and international medical device Standards. Voluntary consensus Standards cover issues ranging from safety and performance to sterilisation guidelines and healthcare technology management.

AAMI is an accredited Standards Development Organisation with the American National Standards Institute (ANSI). It holds the Secretariat for numerous technical committees and subcommittees for the International Organization for Standardisation (ISO) and International Electrotechnical Commission (IEC).

In addition, AAMI provides practical information, training and support for members, and healthcare technology and sterilisation professionals.


Intertek Inform: Your Gateway to AAMI Standards

Intertek Inform makes it easy for businesses to buy AAMI Standards from our website, giving convenient access to globally recognised guidelines set by the Association for the Advancement of Medical Instrumentation. Our Standards Store offers fast access to essential information about compliance with medical device Standards.


On our website, you can purchase individual AAMI Standards in digital PDF or printed (hardcopy) formats. Or you may wish to manage your Standards with i2i, our secure, configurable, cloud-based platform, made available through our subscription service.

 

Packaging for terminally sterilized medical devices—Part 2
Published: 01-Aug-2024
Aseptic processing of health care products—Part 1: General requirements
Published: 01-Aug-2024
Packaging for terminally sterilized medical devices—Part 1
Published: 01-Aug-2024
Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing
Published: 16-Jul-2024
General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
Published: 07-Jun-2024
Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
Published: 30-Apr-2024
Processing of health care products—Quality management systems for processing in health care facilities
Published: 16-Apr-2024
Sterilization of health care products— Biological indicators—Part 1: General requirements
Published: 16-Apr-2024
Sterilization of health care products—Biological indicators—Part 5
Published: 16-Apr-2024
Sterilization of health care products—Biological indicators—Part 3
Published: 16-Apr-2024
Sterilization of health care products— Biological indicators—Part 4
Published: 16-Apr-2024
Sterilization of health care products—Biological indicators—Part 2
Published: 16-Apr-2024
Physical aspects of ethylene oxide sterilization
Published: 26-Mar-2024
Contract sterilization using ethylene oxide
Published: 26-Mar-2024
Product adoption and process equivalence for ethylene oxide sterilization
Published: 26-Mar-2024
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
Published: 26-Mar-2024
Microbiological methods—Understanding and use of product bioburden data
Published: 21-Mar-2024
Sterilization of health care products— Chemical indicators—Part 6
Published: 09-Feb-2024
Microbiological aspects of ethylene oxide sterilization
Published: 18-Dec-2023
Biological evaluation of medical devices— Part 19
Published: 18-Dec-2023
Sterilization of health care products—Microbiological methods—Part 1
Published: 18-Dec-2023
Biological evaluation of medical devices—Part 14
Published: 09-Oct-2023
Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices
Published: 09-Oct-2023
Biological evaluation of medical devices—Part 3
Published: 09-Oct-2023

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Frequently Asked Questions

Below are some of the most common questions about the Association for the Advancement of Medical Instrumentation.

AAMI is a non-profit association committed to advancing safety in health technology and promoting best practices within the industry to improve patient care.

The association provides global leadership in developing voluntary consensus Standards, technical information reports and other industry documents. These resources guide safe and effective medical device manufacture, healthcare technology management and sterilisation practices.

AAMI is an accredited Standards Development Organisation with the American National Standards Institute (ANSI) and administers numerous International Organisation for Standardisation (ISO) and International Electrotechnical Commission (IEC) technical committees and subcommittees.

AAMI is the primary source of national and international voluntary consensus Standards and technical information reports. The process of developing Standards involves 170 committees and working groups, including at least 3,000 health technology industry representatives. Regulators, clinicians, academics and government agencies contribute as well. Many committees also serve as US Technical Advisory Groups. AAMI holds the Secretariat for numerous ISO and IEC technical committees and subcommittees.

AAMI also offers courses, conferences, webinars and publications to provide industry information, technology updates, training and support for members and other industry professionals.

AAMI was founded in 1967 by a group of medical device manufacturers, inventors and physicians. The non-profit organisation is based in Arlington, Virginia, in the US. It is governed by a Board of Directors that includes health technology innovators, healthcare technology management professionals, government regulators, clinicians, educators and Standards experts. The board works with the President and Chief Executive Officer, as well as subcommittees with industry representatives.

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