Association for the Advancement of Medical Instrumentation (AAMI)
AAMI standards play a vital role in guiding manufacturers, healthcare providers, regulators, and other stakeholders in the development, production, and use of medical devices—ensuring patient safety and supporting improved healthcare outcomes.
Nimonik provides seamless access to official AAMI standards in PDF and print formats through our Standards Store, as well as through a subscription service available to your entire team. We take pride in our strong relationships with standards development organizations (SDOs) and the customers we serve.
Popular AAMI Standards
| Standard Code | Title | Format Available |
|---|---|---|
| AAMI ST98 | Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices | PDF, Print |
| ANSI/AAMI ST108 | Water for the processing of medical devices | PDF, Print |
| AAMI TIR97 | Principles for medical device security—Postmarket risk management for device manufacturers | PDF, Print |
| AAMI TIR 106 | Microbiological methods—Understanding and use of product bioburden data | PDF, Print |
| AAMI TIR28 | Sterilization of medical devices. Requirements for medical devices to be designated ‘STERILE’ | PDF, Print |
About AAMI and AAMI Standards
Established in 1967, the Association for the Advancement of Medical Instrumentation® (AAMI) is accredited as a standards development organization recognized by the American National Standards Institute (ANSI). This accreditation affirms that AAMI adheres to ANSI’s fundamental criteria of openness, balance, consensus, and due process in developing American National Standards.
For over 50 years, AAMI has led the development of voluntary consensus standards, technical reports, and other documents with the help of their diverse community of over 10,000 professionals with a crucial mission of developing, managing, and utilizing safe and effective health technology.
As the primary source of national and international consensus standards for the medical device industry, AAMI provides practical information, support, and guidance for healthcare technology and sterilization professionals.
