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.
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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.