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AAMI-Association for the Advancement of Medical Instrumentation
Essential AAMI Standards & Medical Device Guidelines
The Association for the Advancement of Medical Instrumentation (AAMI) sets the benchmark for national and international safety standards across the medical device industry. Designed to support biomedical engineers, clinical technicians, and infection prevention specialists, AAMI publications deliver practical insights for operational compliance and equipment maintenance.
Explore our complete library of ANSI/AAMI standards, practical guidebooks, and training resources covering steam sterilization, biomedical equipment management, and healthcare technology safety protocols.
AAMI TIR37-2013 PDF
This technical information report (TIR) provides guidance for development, validation and routine co..
AAMI TIR38-2019/(R)2026 PDF
This technical information report provides guidance on how to complete an Assurance Case Report in o..
AAMI TIR39-2009/(R)2022 PDF
This technical information report (TIR) provides guidance on selecting the appropriate form of micro..
AAMI TIR40-2018 (R2022) PDF
This technical information report describes the approach for establishing a sterilization dose utili..
AAMI TIR41-2011/(R)2025 PDF
This Technical Information Report provides guidance for the color coding and marking of IS-1, DF-1, ..
AAMI TIR42-2021 PDF
This document provides information for defining appropriate test methods, determining the source of ..
AAMI TIR43-2021/(R)2025 PDF
Addresses preparation and use of ultrapure fluids to perform hemodialysis. Fluids include water and ..
AAMI TIR44-2012 PDF
This technical information report (TIR) discusses the potential sources of motion artifact noise aff..
AAMI TIR45-2023 PDF
Over the past several years, agile software development has become an accepted method for developing..
AAMI TIR48-2024 PDF
This Technical Information Report (TIR) provides information about how to effectively implement the ..