Standards
For almost 60 years, AAMI has been at the forefront in developing voluntary consensus standards, technical information reports, and other technical documents. These standards, developed through the coordination of volunteers from around the world, are used throughout the healthcare field to ensure the safe and effective production, distribution, and use of health technology.
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Standards Development
Enhance the safety and efficacy of a wide range of health technologies.
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Volunteers serve more than 200 committees and working groups.
More about Standards
Standards, TIRs, and other documents are developed by more than 200 technical committees and working groups representing a wide variety of stakeholders in the health technology industry including: manufacturing, testing, distribution, servicing, academia, healthcare institutions, clinicians, and governmental agencies.
AAMI is an accredited standards development organization by the American National Standards Institute (ANSI) which signifies that the procedures we use to develop American National Standards meet ANSI’s essential requirements for openness, balance, consensus, and due process.
AAMI also administers numerous international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) and is accredited by ANSI to administer 18 U.S. Technical Advisory Groups that develop and coordinate U.S. positions on ISO and IEC standardization activities.
Our Standards Philosophy
AAMI’s standards philosophy is grounded in the principle that standards should only be developed when there is clear need and that there should be at most one product/process and one standard, worldwide.
Standards Monitor Online
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